Back to results

Buprenorphine Maintenance Protocol - 1

Primary Purpose

Opioid-Related Disorders

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Friends Research Institute

Outcomes

Primary Outcome Measures

Retention

Opiate use

Opiate craving

Adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT00000205

First Posted

September 20, 1999

Last Updated

July 7, 2016

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00000205

Brief Title

Buprenorphine Maintenance Protocol - 1

Official Title

Buprenorphine Maintenance Protocol

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

October 1990 (undefined)

Primary Completion Date

March 1993 (Actual)

Study Completion Date

September 1993 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Enrollment

0 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Primary Outcome Measure Information:

Title

Retention

Title

Opiate use

Title

Opiate craving

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter Ling, M.D.

Organizational Affiliation

Friends Research Institute, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friends Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8624183

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. doi: 10.1001/archpsyc.1996.01830050035005.

Results Reference

background

PubMed Identifier

8555282

Citation

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.

Results Reference

background

PubMed Identifier

8704003

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. doi: 10.1300/J069v15n02_07.

Results Reference

background

Learn more about this trial

Buprenorphine Maintenance Protocol - 1

We'll reach out to this number within 24 hrs