Trial Outcomes & Findings for Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT) (NCT NCT04180020)
NCT ID: NCT04180020
Last Updated: 2026-07-14
Results Overview
Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
171 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
Treatment as Usual (TAU).
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
|
Overall Study
missed 12 week visit
|
18
|
16
|
|
Overall Study
COMPLETED
|
63
|
59
|
|
Overall Study
NOT COMPLETED
|
22
|
27
|
Reasons for withdrawal
| Measure |
Treatment as Usual (TAU).
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Overall Study
missed visit
|
18
|
16
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
incarcerated
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Baseline characteristics by cohort
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=9 Participants
|
38 years
n=27 Participants
|
39 years
n=267 Participants
|
|
Sex/Gender, Customized
Men
|
42 Participants
n=9 Participants
|
46 Participants
n=27 Participants
|
88 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Women
|
43 Participants
n=9 Participants
|
39 Participants
n=27 Participants
|
82 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Transgender women
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=9 Participants
|
82 Participants
n=27 Participants
|
153 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
137 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=9 Participants
|
86 participants
n=27 Participants
|
171 participants
n=267 Participants
|
|
Housing Status
Unhoused
|
21 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Housing Status
Unstable Housing
|
37 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
67 Participants
n=267 Participants
|
|
Housing Status
Stable Housing
|
27 Participants
n=9 Participants
|
34 Participants
n=27 Participants
|
61 Participants
n=267 Participants
|
|
Housing Status
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Education
High School or above
|
68 Participants
n=9 Participants
|
67 Participants
n=27 Participants
|
135 Participants
n=267 Participants
|
|
Education
Less than high school
|
17 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Education
Did not respond
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Marital Status
Living with partner
|
5 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Marital Status
Married
|
10 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Marital Status
Divorced
|
18 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Marital Status
Never married
|
40 Participants
n=9 Participants
|
29 Participants
n=27 Participants
|
69 Participants
n=267 Participants
|
|
Marital Status
Separated
|
10 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Marital Status
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Income group
Less than $5,000
|
27 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Income group
$5,000-9,999
|
6 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Income group
$10.000-24,999
|
20 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Income group
$25,000-49,999
|
16 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Income group
$50,000 or more
|
15 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Income group
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Type of insurance
Medicaid
|
38 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
76 Participants
n=267 Participants
|
|
Type of insurance
Medicare
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Type of insurance
Private insurance
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Type of insurance
Other insurance
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Type of insurance
None
|
39 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
74 Participants
n=267 Participants
|
|
Type of insurance
Did not respond
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Engaged in condomless sex
Yes
|
48 Participants
n=9 Participants
|
46 Participants
n=27 Participants
|
94 Participants
n=267 Participants
|
|
Engaged in condomless sex
No
|
36 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
71 Participants
n=267 Participants
|
|
Engaged in condomless sex
Did not respond
|
1 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Median number of condomless sex partners
|
1 partners
n=9 Participants
|
1 partners
n=27 Participants
|
1 partners
n=267 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Physical Health
|
42.9 score on a scale
n=9 Participants
|
39.3 score on a scale
n=27 Participants
|
39.3 score on a scale
n=267 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Psychological
|
45.8 score on a scale
n=9 Participants
|
45.8 score on a scale
n=27 Participants
|
45.8 score on a scale
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Missing
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Social Relationships
|
45.8 score on a scale
n=9 Participants
|
54.2 score on a scale
n=27 Participants
|
50.0 score on a scale
n=267 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Environmental
|
53.1 score on a scale
n=9 Participants
|
56.7 score on a scale
n=27 Participants
|
56.3 score on a scale
n=267 Participants
|
|
Provisional Post-traumatic stress disorder (PTSD) Diagnosis
|
48 Participants
n=9 Participants
|
45 Participants
n=27 Participants
|
93 Participants
n=267 Participants
|
|
Depression Severity
None or mild
|
26 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
49 Participants
n=267 Participants
|
|
Depression Severity
Moderate or above
|
57 Participants
n=9 Participants
|
60 Participants
n=27 Participants
|
117 Participants
n=267 Participants
|
|
Depression Severity
Did not answer
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Provisional Attention-deficit/hyperactivity disorder (ADHD)
|
50 Participants
n=9 Participants
|
62 Participants
n=27 Participants
|
112 Participants
n=267 Participants
|
|
Pain Scale score via Pain, Enjoyment of Life and General Activity (PEG) Scale
|
6.0 score on a scale
n=9 Participants
|
6.0 score on a scale
n=27 Participants
|
6.0 score on a scale
n=267 Participants
|
|
Opioid Craving Scale
|
1.00 score on a scale
n=9 Participants
|
1.00 score on a scale
n=27 Participants
|
1.00 score on a scale
n=267 Participants
|
|
Opioid withdrawal (mild or greater)
|
19 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Hazardous/Harmful Drinking
|
23 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
38 Participants
n=267 Participants
|
|
Co-occurring stimulant use disorder
|
48 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
92 Participants
n=267 Participants
|
|
Prescribed MOUD in past 30 days
|
15 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Negative
|
71 Participants
n=9 Participants
|
61 Participants
n=27 Participants
|
132 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Positive
|
11 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Missing
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Negative
|
62 Participants
n=9 Participants
|
64 Participants
n=27 Participants
|
126 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Positive
|
20 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
40 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Missing
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Negative
|
42 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
86 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Positive
|
39 Participants
n=9 Participants
|
40 Participants
n=27 Participants
|
79 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Negative
|
67 Participants
n=9 Participants
|
62 Participants
n=27 Participants
|
129 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Positive
|
14 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Missing
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Negative
|
29 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
56 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Positive
|
51 Participants
n=9 Participants
|
57 Participants
n=27 Participants
|
108 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Missing
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Negative
|
77 Participants
n=9 Participants
|
81 Participants
n=27 Participants
|
158 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Positive
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Missing
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Negative
|
70 Participants
n=9 Participants
|
77 Participants
n=27 Participants
|
147 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Positive
|
12 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Missing
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Negative
|
62 Participants
n=9 Participants
|
55 Participants
n=27 Participants
|
117 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Positive
|
20 Participants
n=9 Participants
|
29 Participants
n=27 Participants
|
49 Participants
n=267 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Missing
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · No
|
27 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · Yes
|
57 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
115 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · No
|
68 Participants
n=9 Participants
|
64 Participants
n=27 Participants
|
132 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · Yes
|
16 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
37 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · No
|
45 Participants
n=9 Participants
|
49 Participants
n=27 Participants
|
94 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · Yes
|
39 Participants
n=9 Participants
|
36 Participants
n=27 Participants
|
75 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · No
|
78 Participants
n=9 Participants
|
76 Participants
n=27 Participants
|
154 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · Yes
|
6 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · No
|
56 Participants
n=9 Participants
|
55 Participants
n=27 Participants
|
111 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · Yes
|
28 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
58 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · No
|
45 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
89 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · Yes
|
39 Participants
n=9 Participants
|
41 Participants
n=27 Participants
|
80 Participants
n=267 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Visited health care provider in last 12 months, excluding urgent care
|
34 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
62 Participants
n=267 Participants
|
|
Covered by health insurance 30 days before interview
|
46 Participants
n=9 Participants
|
50 Participants
n=27 Participants
|
96 Participants
n=267 Participants
|
|
Engaged in injection drug use
No
|
31 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Engaged in injection drug use
Yes
|
53 Participants
n=9 Participants
|
64 Participants
n=27 Participants
|
117 Participants
n=267 Participants
|
|
Engaged in injection drug use
Missing
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Shared injection drug equipment
No
|
35 Participants
n=9 Participants
|
42 Participants
n=27 Participants
|
77 Participants
n=267 Participants
|
|
Shared injection drug equipment
Yes
|
18 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Shared injection drug equipment
Missing
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Shared injection drug equipment
Does not apply
|
31 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Index Infection
HIV diagnosis
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Index Infection
HIV viral load ≥ 200
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Index Infection
Hepatitis C, Ab positive
|
53 Participants
n=9 Participants
|
61 Participants
n=27 Participants
|
114 Participants
n=267 Participants
|
|
Index Infection
Hepatitis C, with detectable viral load
|
36 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
71 Participants
n=267 Participants
|
|
Index Infection
Hepatitis B
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Index Infection
Bloodstream infection
|
36 Participants
n=9 Participants
|
41 Participants
n=27 Participants
|
77 Participants
n=267 Participants
|
|
Index Infection
Endocarditis
|
15 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
35 Participants
n=267 Participants
|
|
Index Infection
Septic arthritis
|
14 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
|
Index Infection
Osteomyelitis
|
16 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Index Infection
Pneumonia/respiratory infection (non-COVID-19)
|
19 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Index Infection
Septic thrombophlebitis
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Index Infection
Skin/skin structure infection
|
11 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
35 Participants
n=267 Participants
|
|
Index Infection
Abscess including skin/soft tissue, intra-abdominal, epidural, and other
|
30 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
57 Participants
n=267 Participants
|
|
Index Infection
COVID-19 Infection
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Index Infection
Sexually transmitted infection
|
3 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Index Infection
Other
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 12 weeksEnrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants With Retention in Medication Treatment for OUD
|
46 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 4 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug using calendars and memory aids to enhance recall.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Days of Using Opioids
|
7.95 days
Standard Error 1.74
|
9.15 days
Standard Error 1.89
|
SECONDARY outcome
Timeframe: From Week 4 to 8This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use, route of use, and form of drug since the last assessment, using calendars and memory aids to enhance recall.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Days of Using Opioids
|
12.09 days
Standard Error 2.07
|
13.20 days
Standard Error 1.93
|
SECONDARY outcome
Timeframe: From Week 8 to 12This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use, route of use, and form of drug since the last assessment, using calendars and memory aids to enhance recall.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Days of Using Opioids
|
12.50 days
Standard Error 2.13
|
11.25 days
Standard Error 2.08
|
SECONDARY outcome
Timeframe: 24 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug using calendars and memory aids to enhance recall.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Days of Using Opioids
|
15.17 days
Standard Error 2.08
|
14.38 days
Standard Error 2.00
|
SECONDARY outcome
Timeframe: 1 weekThis outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Negative Urine Screens: Opioids
|
85 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 4 weeksThis outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Negative Urine Screens: Opioids
|
51 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 8 weeksThis outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Negative Urine Screens: Opioids
|
50 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThis outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Negative Urine Screens: Opioids
|
47 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 24 weeksThis outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Negative Urine Screens: Opioids
|
53 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data only collected for those that completed treatment.
This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy. Data presented here is the number of participants that successfully completed treatment.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Treatment Completion
|
67 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 12 weeksRe-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period. These data are operationalized as the total number of patients experiencing rehospitalization by 12 Weeks.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Re-hospitalization/Emergency Room Visits
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksQuality of life is measured using the World Health Organization Quality Of Life short tool (WHOQOL-Bref), which is a is a well validated and widely used 26-question tool for persons with substance use disorders that measures the perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Scores range from a minimum of 0 to a maximum of 130. Higher scores indicate a higher quality of life.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Quality of Life Measure of Social and Occupational Functioning
|
82.53 score on a scale
Standard Error 1.97
|
86.77 score on a scale
Standard Error 1.87
|
SECONDARY outcome
Timeframe: 24 weeksQuality of life is measured using the World Health Organization Quality Of Life short tool (WHOQOL-Bref), which is a is a well validated and widely used 26-question tool for persons with substance use disorders that measures the perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Scores range from a minimum of 0 to a maximum of 130. Higher scores indicate a higher quality of life.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Quality of Life Measure of Social and Occupational Functioning
|
82.69 score on a scale
Standard Error 2.23
|
87.28 score on a scale
Standard Error 1.87
|
SECONDARY outcome
Timeframe: 4 weeksA modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Modified PEG Pain Scale Score
|
3.7 score on a scale
Standard Error 0.368
|
3.76 score on a scale
Standard Error 0.514
|
SECONDARY outcome
Timeframe: 8 weeksA modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Modified PEG Pain Scale Score
|
3.58 score on a scale
Standard Error 0.529
|
3.65 score on a scale
Standard Error 0.534
|
SECONDARY outcome
Timeframe: 12 weeksA modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Modified PEG Pain Scale Score
|
3.68 score on a scale
Standard Error 0.447
|
2.82 score on a scale
Standard Error 0.476
|
SECONDARY outcome
Timeframe: 24 weeksA modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Modified PEG Pain Scale Score
|
3.41 score on a scale
Standard Error 0.49
|
2.78 score on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: 4 WeeksNumber of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
|
15 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksNumber of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksNumber of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksNumber of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksNumber of Participants Who Had A Needle Sharing Activity in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksNumber of Participants Who Had A Needle Sharing Activity in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksNumber of Participants Who Had A Needle Sharing Activity in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksNumber of Participants Who Had A Needle Sharing Activity in the Past 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksParticipants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Treatment Satisfaction
Yes
|
41 Participants
|
47 Participants
|
|
Treatment Satisfaction
No
|
44 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksParticipants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Treatment Satisfaction
Yes
|
35 Participants
|
30 Participants
|
|
Treatment Satisfaction
No
|
50 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: baselineNumber of participants that had an Unplanned Medical Discharge at baseline
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=84 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=85 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Unplanned Medical Discharge
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksNumber of participants cured of index infection. Clinical adjudication was made based on EHR review including documentation from treating providers, laboratory analyses, available microbiologic information, and imaging.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=84 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=82 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Cure of Index Infection
|
68 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Only those diagnosed with HCV at registration provided these data.
Number of participants with HCV detectable viral load, as determined through RNA polymerase chain reaction (PCR) testing. A viral load above 15 international units per liter (IU/L) is considered detectable and is an indication of active infection and that treatment should be considered
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=59 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=56 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants With Hepatitis C (HCV) Detectable Viral Load
|
40 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: up to 12 WeeksNumber of participants with a viral load by nucleic acid amplification test of more than 200 IU/mL, of those with HIV. A viral load of 200 copies/mL or less is considered 'undetectable' with no risk of HIV transmission.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=2 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=1 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants With Detectable HIV Viral Load
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksMean days participants have injected drugs in the last 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Injecting Drugs
|
6.5 days
Standard Error 2.03
|
8.37 days
Standard Error 2.08
|
SECONDARY outcome
Timeframe: 8 weeksMean days participants have injected drugs in the last 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Injecting Drugs
|
10.37 days
Standard Error 2.47
|
12.79 days
Standard Error 2.04
|
SECONDARY outcome
Timeframe: 12 weeksMean days participants have injected drugs in the last 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Injecting Drugs
|
10.34 days
Standard Error 2.39
|
10.76 days
Standard Error 2.23
|
SECONDARY outcome
Timeframe: 24 weeksMean days participants have injected drugs in the last 28 days
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Injecting Drugs
|
13.15 days
Standard Error 2.36
|
13.39 days
Standard Error 2.13
|
SECONDARY outcome
Timeframe: 4 weeksMean days using other drugs/alcohol (including THC) in last 28 days by self-report
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Other Drug Use
|
4.83 days
Standard Error 1.46
|
6.76 days
Standard Error 1.71
|
SECONDARY outcome
Timeframe: 8 weeksMean days using other drugs/alcohol (including THC) in last 28 days by self-report
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Other Drug Use
|
8.13 days
Standard Error 1.78
|
7.8 days
Standard Error 1.79
|
SECONDARY outcome
Timeframe: 12 weeksMean days using other drugs/alcohol (including THC) in last 28 days by self-report
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Other Drug Use
|
10.85 days
Standard Error 1.73
|
6.74 days
Standard Error 1.73
|
SECONDARY outcome
Timeframe: 24 weeksMean days using other drugs/alcohol (including THC) in last 28 days by self-report
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Mean Days Other Drug Use
|
13.76 days
Standard Error 2.00
|
8.63 days
Standard Error 2.01
|
SECONDARY outcome
Timeframe: 4 weeksNumber of participants with Urine toxicology positive for non-opioid drugs (including THC)
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Urine Toxicology: Positive Screens
|
30 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of participants with Urine toxicology positive for non-opioid drugs (including THC)
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Urine Toxicology: Positive Screens
|
31 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants with Urine toxicology positive for non-opioid drugs (including THC)
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Urine Toxicology: Positive Screens
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 24 weeksNumber of participants with Urine toxicology positive for non-opioid drugs (including THC)
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Urine Toxicology: Positive Screens
|
37 Participants
|
24 Participants
|
Adverse Events
Treatment as Usual (TAU).
Serious events: 35 serious events
Other events: 68 other events
Deaths: 4 deaths
ID/LAB
Serious events: 35 serious events
Other events: 67 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment as Usual (TAU).
n=85 participants at risk
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 participants at risk
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Infections and infestations
Wound infection
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Wound complication
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Prostate infection
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Pelvic infection
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Injury, poisoning and procedural complications
Other (Overdose)
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Injury, poisoning and procedural complications
Other (Opioid Withdrawal)
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Injury, poisoning and procedural complications
Other (Meth Use)
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Other (Epistaxis)
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Superficial thrombophlebitis
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Hypertension
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Tricuspid valve disease
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Cardiac disorders
Surgical and medical procedures - Other, specify
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Cardiac disorders
Heart failure
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/85 • 24 weeks
|
2.3%
2/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
4.7%
4/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Social circumstances
Other (Incarceration)
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Vascular disorders
Stroke
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Endocrine disorders
Hyperglycemia
|
2.4%
2/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Gastrointestinal disorders
Other (Adominal Pain)
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Endocarditis infective
|
3.5%
3/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Infections and infestations
Sepsis
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Infections and infestations
Bone infection
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.9%
5/85 • 24 weeks
|
7.0%
6/86 • 24 weeks
|
|
Infections and infestations
Lung infection
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Infections and infestations
Soft tissue infection
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
4.7%
4/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
Other adverse events
| Measure |
Treatment as Usual (TAU).
n=85 participants at risk
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 participants at risk
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Nervous system disorders
Opioid Withdrawal
|
10.6%
9/85 • 24 weeks
|
16.3%
14/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin/soft tissue infection
|
10.6%
9/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/85 • 24 weeks
|
9.3%
8/86 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.9%
5/85 • 24 weeks
|
11.6%
10/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
7/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
Nervous system disorders
Headache
|
4.7%
4/85 • 24 weeks
|
10.5%
9/86 • 24 weeks
|
|
Vascular disorders
Edema
|
7.1%
6/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
6/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
4/85 • 24 weeks
|
7.0%
6/86 • 24 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/85 • 24 weeks
|
10.5%
9/86 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
4/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
4/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
General disorders
Diaphoresis
|
3.5%
3/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
General disorders
Fatigue
|
5.9%
5/85 • 24 weeks
|
2.3%
2/86 • 24 weeks
|
|
Immune system disorders
Fever
|
3.5%
3/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Nervous system disorders
Non-fatal opioid overdose
|
7.1%
6/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Nervous system disorders
Insomnia
|
2.4%
2/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
4/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Respiratory infection (not including COVID-19)
|
0.00%
0/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place