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Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

NCT00238914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-01-13

No results posted yet for this study

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.

Conditions

  • Heroin Dependence

Interventions

DRUG

Naltrexone

50mg of oral naltrexone daily

BEHAVIORAL

Behavioral Naltrexone Therapy (BNT)

a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy

BEHAVIORAL

Compliance Enhancement (CE)

a controlled therapy intended to simulate outpatient psychiatric care.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Edward Nunes, M.D. · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-08-31
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00238914 on ClinicalTrials.gov