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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

Phase 2
Withdrawn
Conditions
Heroin Dependence
Opioid-Related Disorders
Registration Number
NCT00000328
Lead Sponsor
University of Colorado, Denver
Brief Summary

The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Detailed Description

S/A brief "Summary for the Public"

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Individuals must be at least 18 years of age, 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.

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Opioid agonist rating
Opioid antagonist rating
Compliance
Addiction Severity Index (ASI) Composite Score Rating
Drug use
Retention
Medication identification
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Colorado Health Sciences Center

🇺🇸

Denver, Colorado, United States

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