Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

Phase 1

Completed

• Conditions: Opioid-Related Disorders

• Registration Number: NCT00000320
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

Detailed Description

1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Study Timeline

• Study Start: 1997-10
• Primary Completion: 1999-08
• Study Completion: 1999-08
• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Status Verified: 2009-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
blood level	across study duration

Secondary Outcome Measures

Name	Time	Method
craving	across study duration
withdrawal symptoms	across study duration
drug use	across study duration

Trial Locations

Locations (1)

Friends Research Institute; 🇺🇸 Los Angeles, California, United States