Clinical Trial: Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

Brief Summary: The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence. This study includes free detox and outpatient treatment for opioid dependence that includes medication and a behavioral intervention.

Detailed Summary:

The goal of this Stage II project is to test the efficacy of a new combination of behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction, and to test a new long-acting depot parenteral formulation of naltrexone in initiating treatment.

  1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy. Hypotheses:
  2. Injections of depot naltrexone will reduce early attrition, improve initial stabilization on oral naltrexone, and improve long-term outcome, particularly when combined with Behavioral Naltrexone Therapy.
  3. Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer, will take more doses of naltrexone, and will provide a higher percentage of opiate-free urines.
  4. Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient, when controlling for patient level commitment.

A critical objective of this current proposal is to improve retention, particularly in the initial weeks of treatment. Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection. By removing the option of stopping naltrexone to sample heroin, a common mode of relapse, we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT, intended to shape strong compliance with oral naltrexone a
Sponsor: New York State Psychiatric Institute

Current Primary Outcome:

  • proportion of patients relapsing to illicit opiates based on urine toxicology and self report. [ Time Frame: over 6 months of trial or length of participation ]
    proportion of patients relapsing to opiate use
  • proportion of patients retained in treatment [ Time Frame: over course of 6 months of trial ]
    proportion of patients retained over the course of the trial


Original Primary Outcome:

  • relapse to illicit opiates based on urine toxicology and self report.
  • retention and initial stabilization on naltrexone based on attrition rates


Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York State Psychiatric Institute

Dates:
Date Received: May 30, 2006
Date Started: June 2002
Date Completion:
Last Updated: October 25, 2012
Last Verified: October 2012