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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:


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
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