Buprenorphine Maintenance Protocol - 1

• ClinicalTrials.gov Identifier: NCT00000205
• Recruitment Status: Completed
• First Posted: September 21, 1999
• Last Update Posted: July 11, 2016
• Sponsor: University of California, Los Angeles
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of California, Los Angeles

Tracking Information

• First Submitted Date: September 20, 1999
• First Posted Date: September 21, 1999
• Last Update Posted Date: July 11, 2016
• Study Start Date: October 1990
• Actual Primary Completion Date: March 1993 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2005)

• Retention
• Opiate use
• Opiate craving
• Adverse events

Original Primary Outcome Measures (submitted: June 23, 2005)

• Opiate craving
• Adverse events
• Retention
• Opiate use

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Buprenorphine Maintenance Protocol - 1
• Official Title: Buprenorphine Maintenance Protocol
• Brief Summary: The purpose of this study is to compare the efficacy of buprenorphine versus methadone.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Masking: Double; Primary Purpose: Treatment
• Condition: Opioid-Related Disorders
• Intervention: Drug: Buprenorphine
• Study Arms: Not Provided

Publications *

• Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.
• Compton PA, Ling W, Charuvastra VC, Wesson DR. Buprenorphine as a pharmacotherapy for cocaine abuse: a review of the evidence. J Addict Dis. 1995;14(3):97-114. doi: 10.1300/J069v14n03_07.
• Compton PA, Ling W, Wesson DR, Charuvastra VC, Wilkins J. Urine toxicology as an outcome measure in drug abuse clinical trials: must every sample be analyzed? J Addict Dis. 1996;15(2):85-92. doi: 10.1300/J069v15n02_07.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 0
• Original Enrollment: Same as current
• Actual Study Completion Date: September 1993
• Actual Primary Completion Date: March 1993 (Final data collection date for primary outcome measure)

Eligibility 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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00000205
• Other Study ID Numbers: NIDA-06082-1; R18DA006082 ( U.S. NIH Grant/Contract ); R18-06082-1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, Los Angeles
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Walter Ling, M.D.; Friends Research Institute, Inc.

• PRS Account: University of California, Los Angeles
• Verification Date: July 2016