Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Study Completion Date

1997-08-31

Brief Summary

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The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

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Detailed Description

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Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

Conditions

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Heroin Dependence Opioid-Related Disorders

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Heroin Dependence

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No