Buprenorphine Maintenance Protocol - 1

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine Maintenance Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000205
• Other study ID #: NIDA-06082-1
• Secondary ID: R18DA006082R18-0
• Status: Completed
• Phase: Phase 3
• First received: September 20, 1999
• Last updated: July 7, 2016
• Start date: October 1990
• Est. completion date: September 1993

Study information

• Verified date: July 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of buprenorphine versus methadone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 1993
• Est. primary completion date: March 1993
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention
Primary	Opiate use
Primary	Opiate craving
Primary	Adverse events