Multicenter Clinical Trial of Buprenorphine - 3 - Full Text View

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

Drug Information available for:

Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind

Official Title:	Multicenter Clinical Trial of Buprenorphine

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
First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000207
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Buprenorphine

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Opioid-Related Disorders

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Narcotic Antagonists

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on December 03, 2008

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