Utilization of primary care settings for opioid agonist maintenance treatment would facilitate expanding access to and availability of this treatment, but there are no studies that have evaluated the counseling needed in this setting to obtain optimal results. Our current study provides evidence of the efficacy of three times per week (3x/wk) buprenorphine (BUP) maintenance, and 3x/wk BUP dosing will facilitate its use for maintenance treatment in a primary care clinic (PCC). Before widespread implementation in this setting, however, it is essential to evaluate the level of counseling needed for patients with differing prognostic risk factors. The proposed study will compare Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM). SMM is a relatively brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions, such as diabetes. EMM provides a more extended opportunity for a primary care practitioner to educate the patient about the recovery process and provide additional advice about lifestyle changes and 12-step participation. Both SMM and EMM can be easily implemented in a PCC. The study will test the hypothesis that EMM has greater efficacy that SMM for reducing illicit opiodi and other drug use during 3x/wk BUP maintenance in a PCC. Additionally, the study will evaluate potential patient predictors of differential treatment response (cocaine abuse or dependence, cluster B personality disorders, unemployment) and explore whether SMM may be sufficient for some patient groups (e.g. employed patients without comorbid substance use or psychiatric disorders). Opioid-dependent subjects (n=168) will be randomly assigned to SMM or EMM in a 24-wekk trial of 3x/wk BUP maintenance in a hospital PCC. Primary outcome measures assessed during the trial include reductions in illicit opioid use and achievement of documented abstinence from illicit opioids, as assessed by 3x/wk urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, and improved health status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems with PCC agonist maintenance treatment will also be evaluated.
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