Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

June 24, 2020 updated by: Yale University

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Study Type

Interventional

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

Yes

Genders Eligible for Study

All

Description

Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study.

Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.

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: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Standard Medical Management with once-weekly medication dispensing
Drug: Buprenorphine
  1. Experimental Standard Medical Management with once-weekly medication dispensing
  2. Experimental Standard Medical Management with thrice-weekly medication dispensing
  3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Experimental: 2
Standard Medical Management with thrice-weekly medication dispensing
Drug: Buprenorphine
  1. Experimental Standard Medical Management with once-weekly medication dispensing
  2. Experimental Standard Medical Management with thrice-weekly medication dispensing
  3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Experimental: 3
Enhanced Medical Management with thrice-weekly medication dispensing
Drug: Buprenorphine
  1. Experimental Standard Medical Management with once-weekly medication dispensing
  2. Experimental Standard Medical Management with thrice-weekly medication dispensing
  3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported frequency of illicit opioid use
Time Frame: 6 months
6 months
Percentage of opioid-negative urine specimens
Time Frame: 6 months
6 months
Maximum number of weeks abstinent from illicit opioids
Time Frame: 6 months
6 months

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2000

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

August 30, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-9803-1
  • R01DA009803 (U.S. NIH Grant/Contract)
  • R01-9803-1

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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