Study Comparing Liquid and Tablet Buprenorphine Formulations - 5 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

November 3, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Drug use
Retention
Drug craving

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000302 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind

Condition ^ICMJE

Heroin Dependence

Intervention ^ICMJE

Drug: Buprenorphine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000302

Responsible Party

Study ID Numbers ^ICMJE

NIDA-09260-5, P50-09260-5

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP