Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

Phase 2

Completed

• Conditions: Heroin Dependence
• Interventions: Drug: Naltrexone; Behavioral: Compliance Enhancement (CE); Behavioral: Behavioral Naltrexone Therapy (BNT)

• Registration Number: NCT00238914
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:

1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy.

2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.

Detailed Description

Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence, but has not been successful clinically because of at least three problems: 1) The transition from opiate to naltrexone precipitates opiate withdrawal unless the patient has been off any opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone doses and begin to experience effects from illicit opiates and become re-addicted, at which point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may produce dysphoria in some patients. The proposed research study will offer opiate dependent patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification at an outside unit, they will be assessed for opiate dependence using the naloxone challenge. Patients will then be either discharged or entered directly into outpatient treatment where they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy" (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the family and social network to reinforce naltrexone compliance and abstinence. In this current investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients are stratified at baseline by presence or absence of lifetime depressive disorder, which the investigators hypothesize will predict dysphoria on naltrexone and non-compliance. Patients are discharged from the hospital, or entered directly, into outpatient treatment at STARS at NYSPI to receive both counseling and Naltrexone, 50 mg per day.

Study Timeline

• Study Start: 1999-08
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-14
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CE plus oral naltrexone	Compliance Enhancement (CE)	Compliance enhancement plus oral naltrexone
BNT plus oral naltrexone	Behavioral Naltrexone Therapy (BNT)	Behavioral naltrexone therapy plus oral naltrexone
BNT plus oral naltrexone	Naltrexone	Behavioral naltrexone therapy plus oral naltrexone
CE plus oral naltrexone	Naltrexone	Compliance enhancement plus oral naltrexone

Primary Outcome Measures

Name	Time	Method
Relapse to heroin addiction	Up to 24 weeks or length of study participation

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States