Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01180647 | Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail | PHASE3 | COMPLETED | 48 | — | — | May 1, 2010 | Jul 1, 2013 | Apr 7, 2016 | 2 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Extended-release naltrexone (XR-NTX) | ACTIVE_COMPARATOR | 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. |
| Motivational Enhancement Counseling Only | PLACEBO_COMPARATOR | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
| Name | Type | Description |
|---|---|---|
| Extended-Release Naltrexone | DRUG | 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 | BEHAVIORAL | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
Inclusion Criteria: * Adults incarcerated in NYC jails with known release date * DSM-IV criteria for current opioid dependence * No current agonist (methadone, buprenorphine) treatment * Currently opioid free by history ('detoxed') and with a negative urine for all opioids * General good health as ...