Multicenter Clinical Trial of Buprenorphine - 3 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 16, 2005

Start Date ^ICMJE

May 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Retention
Opiate use
Opiate craving

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000207 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Multicenter Clinical Trial of Buprenorphine - 3

Official Title ^ICMJE

Multicenter Clinical Trial of Buprenorphine

Brief Summary

The purpose of this study is to test the efficacy and safety of buprenorphine.

Detailed Description

12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in the 1 year extension)

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind

Condition ^ICMJE

Opioid-Related Disorders

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. Self-reported use within the last 30 days. Agreeable to conditions of the 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-hynotics. 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

NCT00000207

Responsible Party

Study ID Numbers ^ICMJE

NIDA-06082-3, R18-06082-3

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

June 1993

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