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NCT00000302 Clinical Trial

Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

Heroin Dependence Clinical Trial

Official title:
Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000302
Other study ID # NIDA-09260-5
Secondary ID P50-09260-5
Status Completed
Phase Phase 3
First received September 20, 1999
Last updated November 3, 2005

Study information
Verified date December 2002
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare liquid and tablet buprenorphine formulations.

Description:

Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine

Locations
Country Name City State
United States Friends Research Institute Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Drug use
Primary Retention
Primary Drug craving
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