Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Yale University

Overview

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)

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous

Interventions

BuprenorphineDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

APT Residential Services Division

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Self-reported frequency of illicit opioid use

Time frame: 6 months

Percentage of opioid-negative urine specimens

Time frame: 6 months

Maximum number of weeks abstinent from illicit opioids

Time frame: 6 months

Data from ClinicalTrials.gov

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