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

NCT00577408 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-25

Study results available
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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.

Conditions

  • Opiate Dependence
  • Heroin Dependence

Interventions

DRUG

depot naltrexone

On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).

DRUG

Oral Naltrexone

For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Edward Nunes, M.D. · Columbia University

  • Maria Sullivan, M.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT00577408 on ClinicalTrials.gov