Combining Behavioral Treatment With Agonist Maintenance - 1

January 12, 2018 updated by: Yale University

Combining Behavioral Treatment With Agonist Maintenance

The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 3

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

  • Child
  • Adult
  • Older 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Methadone + CM (contingency management)
Drug: methadone
medication and behavioral
Experimental: 2
methadone + VC (voucher control)
Drug: methadone
medication and behavioral
Experimental: 3
Buprenorphine + CM
Drug: Buprenorphine
Medication and Behavioral
Experimental: 4
Buprenorphine + VC
Drug: Buprenorphine
Medication and Behavioral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Withdrawal symptoms
Opioid and cocaine use
AIDS risk behavior
Depression
Time Frame: 24 weeks
24 weeks
Social and psychological functioning

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

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

February 1, 1995

Primary Completion (Actual)

February 1, 1999

Study Completion (Actual)

February 1, 1999

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 (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09413-1
  • R01DA009413 (U.S. NIH Grant/Contract)
  • R01-09413-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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