Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | July 2013 |
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as
self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release
from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release
from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment
with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the
activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit
heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid
agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely
to relapse and risk accidental overdose at release. All N=40 participants receive a
two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20)
will be randomized to pre-release treatment with XR-NTX. Immediately and one month following
release, participants will be offered continued psychosocial and medication-assisted
treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second
XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained
opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report
significantly lower rates of sustained opioid relapse following release.
with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the
activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit
heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid
agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely
to relapse and risk accidental overdose at release. All N=40 participants receive a
two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20)
will be randomized to pre-release treatment with XR-NTX. Immediately and one month following
release, participants will be offered continued psychosocial and medication-assisted
treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second
XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained
opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report
significantly lower rates of sustained opioid relapse following release.
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 determined by complete medical interview and physical
examination
- Age 18-60 years.
Exclusion Criteria:
- History of liver failure, cirrhosis, or recent liver function test levels greater
than three times normal
- Pregnancy, lactation, or planning conception
- Active medical illness that might make participation hazardous
- Untreated psychiatric disorder
- History of allergic reaction to naltrexone, PLG (polylactide co-glycolide),
carboxymethylcellulose, or any other components of the diluent.
- Current chronic pain condition treated with opioids.
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