Opiate Dependence Clinical Trial
Official title:
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
| Completed |
NCT01690546 -
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
|
Phase 2 | |
| Completed |
NCT01442493 -
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
|
N/A | |
| Completed |
NCT01389167 -
Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
|
Phase 3 | |
| Completed |
NCT01182402 -
Electronic Compliance Monitoring in Opioid Substitution Treatment
|
N/A | |
| Completed |
NCT00634803 -
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
|
Phase 1/Phase 2 | |
| Completed |
NCT00987961 -
Linking Hospitalized Injection Drug Users to Buprenorphine
|
Phase 3 | |
| Completed |
NCT00757744 -
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
|
Phase 3 | |
| Completed |
NCT00577408 -
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
|
Phase 3 | |
| Completed |
NCT00566969 -
Cocaine Withdrawal and Pharmacotherapy Response
|
N/A | |
| Completed |
NCT00539123 -
Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
|
N/A | |
| Recruiting |
NCT00241930 -
Integrating Buprenorphine Into HIV Treatment
|
Phase 4 | |
| Completed |
NCT00218621 -
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1
|
Phase 2 | |
| Completed |
NCT00406484 -
Brief Introductory Therapy for Opioid Dependence
|
Phase 2 | |
| Completed |
NCT00580827 -
Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers
|
N/A | |
| Completed |
NCT03015597 -
Pilot Study of Contingency Management for Smoking Cessation
|
N/A | |
| Completed |
NCT01393392 -
Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
|
Phase 1 | |
| Completed |
NCT01416584 -
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
|
N/A | |
| Recruiting |
NCT00439049 -
Substance Abuse Pre-Treatment Screening Study
|
||
| Withdrawn |
NCT00398008 -
HIV Risk Reduction and Drug Abuse Treatment in Iran
|
Phase 2 |