Heroin |
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Clinical Trial: Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
This study is not yet open for patient recruitment.
Purpose
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)
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous | Drug: Buprenorphine | Phase II |
MedlinePlus related topics: Drug Abuse; Heroin Abuse; Prescription Drug Abuse
Study Type: Interventional
Study Design: Treatment, Randomized, Uncontrolled
Official Title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
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.
Eligibility
Ages Eligible for Study: 21 Years - 55 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
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.
Location Information
Connecticut
APT Residential Services Division, New Haven, Connecticut, 06519, United States
Richard Schottenfeld, M.D., Principal Investigator, Yale University
More Information
Record last reviewed: December 2002
Last Updated: March 17, 2005
Record first received: August 30, 2001
ClinicalTrials.gov Identifier: NCT00023283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Heroin (Cleveland Clinic)
- Heroin: Abuse and Addiction (Cleveland Clinic)

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