Multicenter Clinical Trial of Buprenorphine - 3

NCT ID: NCT00000207

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1992-05-31

Brief Summary

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The purpose of this study is to test the efficacy and safety of buprenorphine.

Detailed Description

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12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in the 1 year extension)

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Principal Investigators

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Walter Ling, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Friends Research Institute

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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R18DA006082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R18-06082-3

Identifier Type: -

Identifier Source: secondary_id

NIDA-06082-3

Identifier Type: -

Identifier Source: org_study_id

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