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

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 2

Conditions: Heroin Dependence; Opioid-Related Disorders

Treatments: Drug: Opioid-Related Disorders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000328

R01-11160-3

NIDA-11160-3

1R01DA011160 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

S/A brief "Summary for the Public"

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind