Trial Outcomes & Findings for Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail (NCT NCT01180647)
NCT ID: NCT01180647
Last Updated: 2016-04-07
Results Overview
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
COMPLETED
PHASE3
48 participants
Four weeks post-release
2016-04-07
Participant Flow
Recruitment of participants took place at NYC jail medical clinics (Rikers Island; EMTC, RMSC) with follow-up visits taking place at Bellevue Hospital. The last participant completed in June 2013.
Of the 48 consented participants enrolled into study between January 2010-May 2013, 34 were randomized into one of two trial arms, with n=17 to Extended-Release Naltrexone arm and n=17 to the Motivational Enhancement Counseling Only arm (treatment-as-usual).
Participant milestones
| Measure |
Extended-release Naltrexone (XR-NTX)
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Extended-release Naltrexone (XR-NTX)
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
Baseline Characteristics
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Baseline characteristics by cohort
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
n=99 Participants
|
47 years
n=107 Participants
|
44 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
33 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Four weeks post-releasePopulation: One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Post-Release Opioid Relapse
|
6 participants
Interval 1.0 to 16.0
|
15 participants
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: Four weeks post-releasePopulation: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Participation in Community Drug Treatment Post-release
|
19 percentage of participants
|
12 percentage of participants
|
SECONDARY outcome
Timeframe: Four weeks post-releasePopulation: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Any Opioid Use Post-release
|
17 percentage of participants
|
82 percentage of participants
|
SECONDARY outcome
Timeframe: Four weeks post-releaseThis secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Injection Drug Use Post-release
|
25 percentage of participants by arm
|
6 percentage of participants by arm
|
SECONDARY outcome
Timeframe: Four weeks post-releasePopulation: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Accidental Drug Overdose
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Eight weeks post-releasePopulation: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
AEs and SAEs per standard definitions will be measured by self-report.
Outcome measures
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 Participants
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 Participants
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
Adverse Events and Serious Adverse Events
|
5 participants
|
1 participants
|
Adverse Events
Extended-release Naltrexone (XR-NTX)
Motivational Enhancement Counseling Only
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended-release Naltrexone (XR-NTX)
n=16 participants at risk
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
|
Motivational Enhancement Counseling Only
n=17 participants at risk
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
|---|---|---|
|
General disorders
Anticipated XR-NTX Symptoms
|
25.0%
4/16 • Number of events 4 • Adverse Events collected during 8 weeks post-release.
|
0.00%
0/17 • Adverse Events collected during 8 weeks post-release.
|
|
Injury, poisoning and procedural complications
Shoulder Seperation
|
6.2%
1/16 • Number of events 1 • Adverse Events collected during 8 weeks post-release.
|
0.00%
0/17 • Adverse Events collected during 8 weeks post-release.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Problems
|
0.00%
0/16 • Adverse Events collected during 8 weeks post-release.
|
5.9%
1/17 • Number of events 1 • Adverse Events collected during 8 weeks post-release.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place