Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1



Status:Not yet recruiting
Conditions:Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:21 - 55
Updated:4/2/2016
Contact:Richard Schottenfeld, M.D.
Email:richard.schottenfeld@yale.edu
Phone:(203)974-7349

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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)

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.

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.
We found this trial at
1
site
New Haven, Connecticut 06519
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from
New Haven, CT
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