Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • APT Residential Services Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Please contact site for information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Maintenance treatment with daily medication
Drug: Buprenorphine
  1. Experimental Maintenance treatment with daily medication
  2. Experimental Maintenance treatment with thrice-weekly medication
Experimental: 2
Maintenance treatment with thrice-weekly medication
Drug: Buprenorphine
  1. Experimental Maintenance treatment with daily medication
  2. Experimental Maintenance treatment with thrice-weekly medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Opioid and cocaine use
Time Frame: 26 weeks
26 weeks
Social and psychological functioning
Time Frame: 26 weeks
26 weeks
AIDS risk behavior
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1994

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 20, 1999

First Submitted That Met QC Criteria

September 20, 1999

First Posted (Estimate)

September 21, 1999

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09803-1
  • R01-09803-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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