Back to results

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Primary Purpose

Heroin Dependence, Opioid-Related Disorders, Substance Abuse, Intravenous

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Opioid-Related Disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

APT Residential Services Division

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Standard Medical Management with once-weekly medication dispensing

Standard Medical Management with thrice-weekly medication dispensing

Enhanced Medical Management with thrice-weekly medication dispensing

Outcomes

Primary Outcome Measures

Self-reported frequency of illicit opioid use

Percentage of opioid-negative urine specimens

Maximum number of weeks abstinent from illicit opioids

Secondary Outcome Measures

Full Information

NCT ID

NCT00023283

First Posted

August 30, 2001

Last Updated

June 24, 2020

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00023283

Brief Title

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Official Title

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

December 2003 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heroin Dependence, Opioid-Related Disorders, Substance Abuse, Intravenous

Keywords

Opioid-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Standard Medical Management with once-weekly medication dispensing

Arm Title

Arm Type

Experimental

Arm Description

Standard Medical Management with thrice-weekly medication dispensing

Arm Title

Arm Type

Experimental

Arm Description

Enhanced Medical Management with thrice-weekly medication dispensing

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Intervention Description

Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing

Primary Outcome Measure Information:

Title

Self-reported frequency of illicit opioid use

Time Frame

6 months

Title

Percentage of opioid-negative urine specimens

Time Frame

6 months

Title

Maximum number of weeks abstinent from illicit opioids

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Schottenfeld, M.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

APT Residential Services Division

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17933486

Citation

Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.

Results Reference

derived

PubMed Identifier

16870915

Citation

Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O'Connor PG, Schottenfeld RS. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006 Jul 27;355(4):365-74. doi: 10.1056/NEJMoa055255.

Results Reference

derived

Learn more about this trial

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

We'll reach out to this number within 24 hrs