Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone

NCT ID: NCT00000243

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

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-01-31

Brief Summary

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Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Detailed Description

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Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for opioid dependence

Exclusion Criteria

* Significant medical or psychiatric illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Eric C. Strain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01-08045-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-08045-1

Identifier Type: -

Identifier Source: org_study_id

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