Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

NCT ID: NCT00000318

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

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-12-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Detailed Description

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Conditions

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Opioid-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Maintenance treatment with daily medication

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

1. Experimental Maintenance treatment with daily medication
2. Experimental Maintenance treatment with thrice-weekly medication

2

Maintenance treatment with thrice-weekly medication

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

1. Experimental Maintenance treatment with daily medication
2. Experimental Maintenance treatment with thrice-weekly medication

Interventions

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Buprenorphine

1. Experimental Maintenance treatment with daily medication
2. Experimental Maintenance treatment with thrice-weekly medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Yale University School of Medicine

Principal Investigators

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Richard Schottenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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APT Residential Services Division

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R01-09803-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-09803-1

Identifier Type: -

Identifier Source: org_study_id

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