Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicenter Clinical Trial of Buprenorphine - 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000207
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of California, Los Angeles

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to test the efficacy and safety of buprenorphine.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial of Buprenorphine
Study Start Date : May 1992
Actual Primary Completion Date : April 1997

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Retention
  2. Opiate use
  3. Opiate craving

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000207


Locations
Layout table for location information
United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00000207    
Other Study ID Numbers: NIDA-06082-3
R18DA006082 ( U.S. NIH Grant/Contract )
R18-06082-3
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by University of California, Los Angeles:
Buprenorphine
Opioid
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists