Trial Outcomes & Findings for Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry (NCT NCT01999946)
NCT ID: NCT01999946
Last Updated: 2021-06-25
Results Overview
Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized ETAU following release from jail measured up to 24 weeks by Urine Toxicology results and self-report on the TLFB.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
217 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2021-06-25
Participant Flow
Participant milestones
| Measure |
Extended-Release Naltrexone (XR-NTX)
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
|
Enhanced Treatment As Usual (ETAU)
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
|
Methadone Treatment Program (MTP)
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
58
|
79
|
|
Overall Study
COMPLETED
|
59
|
56
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
79
|
Reasons for withdrawal
| Measure |
Extended-Release Naltrexone (XR-NTX)
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
|
Enhanced Treatment As Usual (ETAU)
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
|
Methadone Treatment Program (MTP)
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
|
|---|---|---|---|
|
Overall Study
Participant not released from jail
|
2
|
2
|
0
|
|
Overall Study
Not included in primary outcome analysis
|
0
|
0
|
79
|
Baseline Characteristics
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Baseline characteristics by cohort
| Measure |
Extended-Release Naltrexone (XR-NTX)
n=59 Participants
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
|
Enhanced Treatment As Usual (ETAU)
n=56 Participants
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
|
Methadone Treatment Program (MTP)
n=79 Participants
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.9 • n=39 Participants
|
43.7 years
STANDARD_DEVIATION 9.8 • n=41 Participants
|
43.7 years
STANDARD_DEVIATION 9.7 • n=35 Participants
|
43.5 years
STANDARD_DEVIATION 10.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
162 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
82 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
112 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
93 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
62 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
39 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=39 Participants
|
56 participants
n=41 Participants
|
79 participants
n=35 Participants
|
194 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksPopulation: MTP is a quasi-experimental cohort, so no data was collected for this arm. The primary outcome is a comparison between XR-NTX vs. ETAU only.
Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized ETAU following release from jail measured up to 24 weeks by Urine Toxicology results and self-report on the TLFB.
Outcome measures
| Measure |
Extended-Release Naltrexone (XR-NTX)
n=59 Participants
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
|
Enhanced Treatment As Usual (ETAU)
n=56 Participants
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
|
|---|---|---|
|
Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail
|
8.6 Weeks
Standard Deviation 8.7
|
5.9 Weeks
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: up to 24 weeksOur secondary aim is to measure time-to-relapse among XR-NTX vs. the non-randomized observational Methadone (MTP) cohort up to 24 weeks following release from jail and measured by Urine Toxicology results and self-report on the TLFB.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksCommunity treatment retention/initiation across all arms post-release using the Economic Form 90.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksAny opioid, alcohol, or other illicit drug misuse, defined as continuous counts of both days, amount/day, and urine toxicologies for heroin or other illicit opioid and other drug use across all arms up to 24 weeks post-release and measured by Urine Toxicology Results and the TLFB.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksInjection drug use and HIV sexual risk factors will be assessed across all arms measured post-release from jail and measured using the Risk Assessment Battery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 28 weeksAccidental drug overdose and mortality across all arms assessed at each follow-up study visit up to 28 weeks post-release from jail measured by self report on the Opioid-Overdose AE/SAE form.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksRe-incarceration and exploratory cost-effectiveness will be assessed across all arms up to 24 weeks post-release and measured using self-report on the Arrests and Days Incarcerated form and information received from the NYC DOC Inmate Locator online. Cost-effectiveness will be assessed across all arms and measured by the Economic Form 90.
Outcome measures
Outcome data not reported
Adverse Events
Extended-Release Naltrexone (XR-NTX)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Enhanced Treatment As Usual (ETAU)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Methadone Treatment Program (MTP)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended-Release Naltrexone (XR-NTX)
n=59 participants at risk
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
|
Enhanced Treatment As Usual (ETAU)
n=56 participants at risk
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
|
Methadone Treatment Program (MTP)
n=79 participants at risk
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
|
|---|---|---|---|
|
General disorders
Opioid Overdose
|
1.7%
1/59 • Number of events 1 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
8.9%
5/56 • Number of events 5 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
2.5%
2/79 • Number of events 2 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
|
General disorders
Fatal Opioid Overdose
|
1.7%
1/59 • Number of events 1 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
1.8%
1/56 • Number of events 1 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
0.00%
0/79 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
|
Surgical and medical procedures
Medical Event or Procedure
|
10.2%
6/59 • Number of events 6 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
3.6%
2/56 • Number of events 2 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
6.3%
5/79 • Number of events 5 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
|
General disorders
Death, Unknown Cause
|
0.00%
0/59 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
1.8%
1/56 • Number of events 1 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
0.00%
0/79 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
|
General disorders
Prolonged Hospitalization
|
0.00%
0/59 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
0.00%
0/56 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
3.8%
3/79 • Number of events 3 • Up to 24 weeks
Adverse events were solicited by questionnaire
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place