Multicenter Clinical Trial of Buprenorphine - 3

This study has been completed.

First Received: September 20, 1999 Last Updated: August 16, 2005 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000207

Purpose

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

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind
Official Title:	Multicenter Clinical Trial of Buprenorphine

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention
Opiate use
Opiate craving

Estimated Enrollment:	0
Study Start Date:	May 1992

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)

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000207

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

Publications:

1) Bup maintenance Tx of opiate dependence: A multicenter randomized tiral (Addiction, submitted) 2) Bup as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996;5(3): 220-222.. (1) Buprenorphine maintenance treatment of opiate dependence: A multicenter randomized trial ( Addiction, submitted). (2) Buprenorphine as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996; 5(3):220-222.

Study ID Numbers:	NIDA-06082-3, R18-06082-3
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000207 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Narcotic Antagonists
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009