Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone

Status Completed

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

Clinical Trial Details

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

View Details

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	`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	`NCT00987961` - Linking Hospitalized Injection Drug Users to Buprenorphine	Phase 3
Completed	`NCT00634803` - Clinical Trial of Integrated Treatment for Pain and Opioid Dependence	Phase 1/Phase 2
Completed	`NCT00757744` - Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China	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
Completed	`NCT00622596` - Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone — Depot-BNT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms