Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

NCT ID: NCT00015171

Last Updated: 2017-01-16

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

1996-04-30

Study Completion Date

1997-06-30

Brief Summary

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The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Detailed Description

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The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Conditions

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Heroin Dependence Substance-Related Disorders

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine/naloxone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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John Rotrosen, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York MDRU

Locations

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New York MDRU

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Y01-5-0013-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-5-0013-1

Identifier Type: -

Identifier Source: org_study_id

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