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OpenTrials
Completed

NCT Number: NCT00023283

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

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)

Completed

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

APT Residential Services Division

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine

Drug
  • 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 outcomes

  1. Self-reported frequency of illicit opioid use

    Time frame: 6 months

  2. Percentage of opioid-negative urine specimens

    Time frame: 6 months

  3. Maximum number of weeks abstinent from illicit opioids

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
Aug 31, 2001
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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