Clinical Trials Logo

Clinical Trial Summary

In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide initial clinical experience with the new Depot-BNT treatment model, while providing a rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best behavioral platform for oral naltrexone (BNT).

The following aims will be addressed:

Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key secondary outcomes including dysphoria, HIV risk behavior, and social functioning.

Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition, in order to optimize Depot-BNT prior to further testing.


Clinical Trial Description

The clinical trial now proposed will provide an initial test of the feasibility and efficacy of the newly adapted version of Behavioral Naltrexone Therapy for Depot Naltrexone (Depot-BNT). Treatment-seeking opiate-dependent patients will be admitted for inpatient detoxification and induction onto oral naltrexone. Those who are successfully inducted will be randomly assigned for a six month trial to one of two conditions: 1) Behavioral Naltrexone Therapy for Depot Naltrexone (Depot-BNT) (N = 30), with the first dose of depot naltrexone administered prior to discharge from hospital with monthly doses thereafter; or 2) Behavioral Naltrexone Therapy as previously developed for promoting compliance with daily oral naltrexone (BNT-Oral) (N = 30). All patients in both groups will be asked to attend twice weekly outpatient therapy sessions over a six month course. This design will provide a test of whether Depot-BNT produces superior treatment retention and drug use outcome in comparison to our established behavioral platform for oral naltrexone, while providing experience upon which to base revisions of Depot-BNT prior to embarking upon further Stage 2 testing. Treatment will take place at the same sites as for our prior studies: (1) the General Clinical Research Unit (GCRU) of New York State Psychiatric Institute (NYSPI) and (2) the Substance Treatment and Research Service (STARS) of the Division on Substance Abuse at NYSPI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00577408
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 3
Start date September 2007
Completion date August 2011

See also
  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 NCT01389167 - Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia Phase 3
Completed NCT01442493 - Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment N/A
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 NCT00566969 - Cocaine Withdrawal and Pharmacotherapy Response N/A
Completed NCT00539123 - Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia N/A
Completed NCT00757744 - Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China Phase 3
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
Completed NCT00622596 - Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance N/A