NCT00332228

Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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 Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection.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 and motivation for abstinence and lifestyle change. 160 heroin-dependent individuals seeking treatment will be recruited at PI (STARS) or referred from other sites (e.g., private physician; other detoxification programs). Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months. All enrolled participants will be encouraged to return for follow-up assessment visits at one, three, and six months beyond the completion of their participation for research purposes. Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy (CET), a manual-guided approach developed by Carroll and O'Malley at Yale University as a control condition for psychotherapy studies with substance dependent patients. Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification. Therefore, there will be four treatment conditions with 40 participants per condition. These four conditions include: 1) BNT plus two doses of depot naltrexone prior to hospital discharge; 2) BNT plus two placebo injections; 3) Compliance Enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone injections; and 4) CE plus two placebo injections.

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	depot naltrexone	long-acting depot parenteral formulation of naltrexone
BEHAVIORAL	Compliance enhancement (CE)	Compliance enhancement (CE), simulating standard treatment with oral naltrexone
DRUG	BNT	behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction

Timeline

• Start date: 2002-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-06-01
• Last updated: 2012-10-26

Locations

2 sites across 1 country: United States