Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

• Status: Withdrawn
• Trial end date: 1997-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Heroin; Naloxone

Criteria

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.