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

University of Colorado, Denver

Overview

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

S/A brief "Summary for the Public"

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Heroin Dependence Opioid-Related Disorders

Interventions

Opioid-Related DisordersDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. 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.

Locations (1)

University of Colorado Health Sciences Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Drug use

Retention

Opioid agonist rating

Opioid antagonist rating

Compliance

Medication identification

Addiction Severity Index (ASI) Composite Score Rating

Data from ClinicalTrials.gov

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