Trial Outcomes & Findings for Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management (NCT NCT05204576)
NCT ID: NCT05204576
Last Updated: 2026-05-01
Results Overview
Participants active in MOUD treatment will be verified by TimeLine Follow-back and clinic medical records of dates of medication taken, prescriptions filled and pick up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
At 3, 6 and 9 months post treatment
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Standard Care Treatment as Usual (TAU)
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
Completed 3 Month Follow up
|
71
|
67
|
|
Overall Study
Completed 6 Month Follow up
|
72
|
64
|
|
Overall Study
Completed 9 Month Follow up
|
74
|
70
|
|
Overall Study
Included in ITT Analysis
|
80
|
80
|
|
Overall Study
COMPLETED
|
73
|
69
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management
Baseline characteristics by cohort
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 Participants
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 Participants
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.79 years
STANDARD_DEVIATION 10.06 • n=14 Participants
|
50.89 years
STANDARD_DEVIATION 9.7 • n=34 Participants
|
50.84 years
STANDARD_DEVIATION 9.85 • n=69 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=14 Participants
|
46 Participants
n=34 Participants
|
85 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=14 Participants
|
34 Participants
n=34 Participants
|
75 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=14 Participants
|
13 Participants
n=34 Participants
|
28 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=14 Participants
|
45 Participants
n=34 Participants
|
85 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=14 Participants
|
22 Participants
n=34 Participants
|
47 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
42 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=14 Participants
|
59 Participants
n=34 Participants
|
116 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=14 Participants
|
80 participants
n=34 Participants
|
160 participants
n=69 Participants
|
|
Education- High School GED or College
|
57 Participants
n=14 Participants
|
63 Participants
n=34 Participants
|
120 Participants
n=69 Participants
|
|
Employment
Unemployed
|
60 Participants
n=14 Participants
|
60 Participants
n=34 Participants
|
120 Participants
n=69 Participants
|
|
Employment
Employed
|
20 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
40 Participants
n=69 Participants
|
|
Married/Living with Partner
|
8 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
22 Participants
n=69 Participants
|
|
Has access to a computer/laptop or tablet
|
53 Participants
n=14 Participants
|
55 Participants
n=34 Participants
|
108 Participants
n=69 Participants
|
|
Has a smartphone
|
77 Participants
n=14 Participants
|
77 Participants
n=34 Participants
|
154 Participants
n=69 Participants
|
|
Accesses the internet from smartphone
|
75 Participants
n=14 Participants
|
75 Participants
n=34 Participants
|
150 Participants
n=69 Participants
|
|
How comfortable using a computer or smartphone for treatment purposes
Not at all
|
1 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
How comfortable using a computer or smartphone for treatment purposes
A little
|
7 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
12 Participants
n=69 Participants
|
|
How comfortable using a computer or smartphone for treatment purposes
Somewhat
|
16 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
31 Participants
n=69 Participants
|
|
How comfortable using a computer or smartphone for treatment purposes
Very
|
32 Participants
n=14 Participants
|
29 Participants
n=34 Participants
|
61 Participants
n=69 Participants
|
|
How comfortable using a computer or smartphone for treatment purposes
Extremely
|
24 Participants
n=14 Participants
|
28 Participants
n=34 Participants
|
52 Participants
n=69 Participants
|
|
Current Opioid Use Disorder Severity*
Mild/Moderate
|
31 Participants
n=14 Participants
|
33 Participants
n=34 Participants
|
64 Participants
n=69 Participants
|
|
Current Opioid Use Disorder Severity*
Severe
|
49 Participants
n=14 Participants
|
47 Participants
n=34 Participants
|
96 Participants
n=69 Participants
|
|
Time in Opioid Use Disorder Treatment
Less than 6 months
|
21 Participants
n=14 Participants
|
16 Participants
n=34 Participants
|
37 Participants
n=69 Participants
|
|
Time in Opioid Use Disorder Treatment
6 to 12 months
|
8 Participants
n=14 Participants
|
16 Participants
n=34 Participants
|
24 Participants
n=69 Participants
|
|
Time in Opioid Use Disorder Treatment
More than 12 monts
|
51 Participants
n=14 Participants
|
48 Participants
n=34 Participants
|
99 Participants
n=69 Participants
|
|
On Methadone
|
78 Participants
n=14 Participants
|
80 Participants
n=34 Participants
|
158 Participants
n=69 Participants
|
|
Chronic Pain Scale Score
|
22.85 score on a scale
STANDARD_DEVIATION 3.84 • n=14 Participants
|
21.62 score on a scale
STANDARD_DEVIATION 4.74 • n=34 Participants
|
22.4 score on a scale
STANDARD_DEVIATION 4.34 • n=69 Participants
|
|
Has Overdosed
|
34 Participants
n=14 Participants
|
42 Participants
n=34 Participants
|
76 Participants
n=69 Participants
|
|
Route of Administration
Intranasal
|
42 Participants
n=14 Participants
|
38 Participants
n=34 Participants
|
80 Participants
n=69 Participants
|
|
Route of Administration
Intravenous
|
21 Participants
n=14 Participants
|
22 Participants
n=34 Participants
|
43 Participants
n=69 Participants
|
|
Route of Administration
SB
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Route of Administration
Oral
|
15 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
35 Participants
n=69 Participants
|
|
Type of Opioid Generally Used
Heroin
|
48 Participants
n=14 Participants
|
50 Participants
n=34 Participants
|
98 Participants
n=69 Participants
|
|
Type of Opioid Generally Used
Precription Opioids
|
15 Participants
n=14 Participants
|
23 Participants
n=34 Participants
|
38 Participants
n=69 Participants
|
|
Type of Opioid Generally Used
Fentanyl
|
19 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
26 Participants
n=69 Participants
|
|
Type of Opioid Generally Used
Other Opioids
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Type Opioid First Used
Heroin
|
21 Participants
n=14 Participants
|
23 Participants
n=34 Participants
|
44 Participants
n=69 Participants
|
|
Type Opioid First Used
Other
|
46 Participants
n=14 Participants
|
52 Participants
n=34 Participants
|
98 Participants
n=69 Participants
|
|
Type Opioid First Used
Both Heroin and Other
|
13 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
18 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: At 3, 6 and 9 months post treatmentParticipants active in MOUD treatment will be verified by TimeLine Follow-back and clinic medical records of dates of medication taken, prescriptions filled and pick up.
Outcome measures
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 Participants
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 Participants
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Percent Participants Active in Medications for Opioid Use Disorder (MOUD) Treatment
3 months
|
91.30 Percent participants
|
86.30 Percent participants
|
|
Percent Participants Active in Medications for Opioid Use Disorder (MOUD) Treatment
6 months
|
89.90 Percent participants
|
83.20 Percent participants
|
|
Percent Participants Active in Medications for Opioid Use Disorder (MOUD) Treatment
9 months
|
87.30 Percent participants
|
78.50 Percent participants
|
PRIMARY outcome
Timeframe: Baseline and 12, 24, 36 weeksPain interference is measured using the PROMIS 6-item Pain Interference Short Form. The score range on the PROMIS Pain Form is 6-30, where the highest score is the highest measure of pain interference. Summed raw responses (1-5 scale per item) are converted into a standardized T-score (mean 50, SD 10), where higher scores indicate greater pain interference (worse functioning).
Outcome measures
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 Participants
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 Participants
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Change in PROMIS 6-item Pain Interference Short Form
24 weeks
|
62.36 Tscore
Standard Deviation 5.11
|
60.31 Tscore
Standard Deviation 4.38
|
|
Change in PROMIS 6-item Pain Interference Short Form
Baseline
|
63.06 Tscore
Standard Deviation 5.11
|
63.54 Tscore
Standard Deviation 4.38
|
|
Change in PROMIS 6-item Pain Interference Short Form
12 weeks
|
62.71 Tscore
Standard Deviation 5.11
|
61.92 Tscore
Standard Deviation 4.38
|
|
Change in PROMIS 6-item Pain Interference Short Form
36 weeks
|
62.00 Tscore
Standard Deviation 5.11
|
58.70 Tscore
Standard Deviation 4.38
|
SECONDARY outcome
Timeframe: Baseline to Week 12Opioid and other drug use will be assessed in participants weekly using Urine toxicology screens and Timeline Follow-Back. Baseline to Week 12 during treatment period.
Outcome measures
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 Participants
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 Participants
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Mean Days of Any Drug Use
Baseline
|
2.03 days
Standard Deviation 2.31
|
1.51 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 1
|
2.03 days
Standard Deviation 2.31
|
1.48 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 2
|
2.02 days
Standard Deviation 2.31
|
1.44 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 3
|
2.02 days
Standard Deviation 2.31
|
1.40 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 4
|
2.01 days
Standard Deviation 2.31
|
1.37 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 5
|
2.01 days
Standard Deviation 2.31
|
1.33 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 6
|
2.00 days
Standard Deviation 2.31
|
1.29 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 7
|
2.00 days
Standard Deviation 2.31
|
1.26 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 8
|
1.99 days
Standard Deviation 2.31
|
1.22 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 9
|
1.99 days
Standard Deviation 2.31
|
1.18 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 10
|
1.99 days
Standard Deviation 2.31
|
1.15 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 11
|
1.98 days
Standard Deviation 2.31
|
1.11 days
Standard Deviation 1.89
|
|
Mean Days of Any Drug Use
Week 12
|
1.98 days
Standard Deviation 2.31
|
1.07 days
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Week 12 up to Week 36Opioid and other drug use will be assessed in participants weekly using Urine toxicology screens and Timeline Follow-Back. Weeks 12 to 36 during followup period.
Outcome measures
| Measure |
Standard Care Treatment as Usual (TAU)
n=78 Participants
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=74 Participants
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Mean Days of Any Drug Use
Week 12
|
1.74 days
Standard Deviation 2.25
|
1.07 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 13
|
1.76 days
Standard Deviation 2.25
|
1.07 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 14
|
1.78 days
Standard Deviation 2.25
|
1.07 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 15
|
1.79 days
Standard Deviation 2.25
|
1.08 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 16
|
1.81 days
Standard Deviation 2.25
|
1.08 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 17
|
1.83 days
Standard Deviation 2.25
|
1.08 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 18
|
1.85 days
Standard Deviation 2.25
|
1.09 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 19
|
1.86 days
Standard Deviation 2.25
|
1.09 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 20
|
1.88 days
Standard Deviation 2.25
|
1.09 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 21
|
1.90 days
Standard Deviation 2.25
|
1.10 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 22
|
1.92 days
Standard Deviation 2.25
|
1.10 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 23
|
1.93 days
Standard Deviation 2.25
|
1.10 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 24
|
1.95 days
Standard Deviation 2.25
|
1.11 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 25
|
1.97 days
Standard Deviation 2.25
|
1.11 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 26
|
1.99 days
Standard Deviation 2.25
|
1.11 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 27
|
2.00 days
Standard Deviation 2.25
|
1.12 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 28
|
2.02 days
Standard Deviation 2.25
|
1.12 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 29
|
2.04 days
Standard Deviation 2.25
|
1.12 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 30
|
2.06 days
Standard Deviation 2.25
|
1.13 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 31
|
2.07 days
Standard Deviation 2.25
|
1.13 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 32
|
2.09 days
Standard Deviation 2.25
|
1.14 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 33
|
2.11 days
Standard Deviation 2.25
|
1.14 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 34
|
2.13 days
Standard Deviation 2.25
|
1.14 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 35
|
2.14 days
Standard Deviation 2.25
|
1.15 days
Standard Deviation 1.88
|
|
Mean Days of Any Drug Use
Week 36
|
2.16 days
Standard Deviation 2.25
|
1.15 days
Standard Deviation 1.88
|
Adverse Events
Standard Care Treatment as Usual (TAU)
Serious events: 18 serious events
Other events: 5 other events
Deaths: 1 deaths
IMPACT + TAU
Serious events: 23 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 participants at risk
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 participants at risk
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for overdose
|
1.2%
1/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Psychiatric disorders
Inpatient detox adminsion
|
12.5%
10/80 • 36 weeks
|
11.2%
9/80 • 36 weeks
|
|
Psychiatric disorders
Inpatient admission for mental health
|
2.5%
2/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
General disorders
Hospitalization for allergic reaction
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Blood and lymphatic system disorders
Hospitalization for anemia
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for back pain
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Gastrointestinal disorders
Hospitalization for bleeding in small intestines
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Cardiac disorders
Hospitalization for blood clot
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Metabolism and nutrition disorders
Hopsitalization for diabetes complications
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Injury, poisoning and procedural complications
Hospitalization for chest injury
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Gastrointestinal disorders
Hospitalization for colon rupture
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Infections and infestations
Hospitalization for COPD
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Infections and infestations
Hospitalization for Covid 19
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
General disorders
Hospitalization for fatigue
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Gastrointestinal disorders
Hospitalization for feeding tube
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Injury, poisoning and procedural complications
Hospitalization for food poisoning
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Infections and infestations
Hospitalization for kidney infection
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Infections and infestations
Hospitalization for leg infection
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Hepatobiliary disorders
Hospitalization for liver failure
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Nervous system disorders
Hospitalization for menignioma
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Surgical and medical procedures
Hospitalization for neck surgery
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Surgical and medical procedures
Hospitalization for oral surgery
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Nervous system disorders
Hospitalization for seizures
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Infections and infestations
Hospitallization for spinal infection
|
0.00%
0/80 • 36 weeks
|
1.2%
1/80 • 36 weeks
|
|
Gastrointestinal disorders
Hospitalization for stomach pain
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Surgical and medical procedures
Hospitalization for stomach surgery
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
Gastrointestinal disorders
Hospitalization for stomach ulcers
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
|
General disorders
Hospitalization for sweling of legs/feet
|
1.2%
1/80 • 36 weeks
|
0.00%
0/80 • 36 weeks
|
Other adverse events
| Measure |
Standard Care Treatment as Usual (TAU)
n=80 participants at risk
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
|
IMPACT + TAU
n=80 participants at risk
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
CBT4CBT COPES: Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls
|
|---|---|---|
|
Injury, poisoning and procedural complications
Back pain
|
6.2%
5/80 • 36 weeks
|
7.5%
6/80 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place