Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

NCT ID: NCT00015340

Last Updated: 2017-01-12

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

PHASE4

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2001-09-30

Brief Summary

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The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Detailed Description

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The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Conditions

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Opioid Dependence Substance-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buprenorphine/Naloxone

Group Type EXPERIMENTAL

Buprenorphine/naloxone

Intervention Type DRUG

Interventions

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Buprenorphine/naloxone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Completion of Cooperative Study 1008 A/B

Exclusion Criteria

\- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York MDRU

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Paul Casadonte, M.D.

Role: STUDY_CHAIR

New York VAMC

Locations

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University of California

Los Angeles, California, United States

Site Status

VA Medical Center

Tampa, Florida, United States

Site Status

VA Medical Center

Hines, Illinois, United States

Site Status

New York VAMC

New York, New York, United States

Site Status

VA PUget Sound Helath Care System

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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Y01-5-0013-14

Identifier Type: -

Identifier Source: secondary_id

NIDA-5-0013-14

Identifier Type: -

Identifier Source: org_study_id

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