Multicenter Clinical Trial of Buprenorphine - 3

Opioid-Related Disorders Clinical Trial

Official title:

Multicenter Clinical Trial of Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000207
• Other study ID #: NIDA-06082-3
• Secondary ID: R18DA006082R18-0
• Status: Completed
• Phase: Phase 3
• First received: September 20, 1999
• Last updated: July 7, 2016
• Start date: May 1992

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 test the efficacy and safety of buprenorphine.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 1997
• 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 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.

Study Design

Allocation: Randomized, 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 (1)

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.

Outcome

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