The efficacy of Buprenorphine (Bup) as a treatment for opioid dependence has been established in trials that included on-site drug counseling. In an effort to expand access to treatment for opioid dependence, new regulations make Bup available in primary care without obligate counseling. Despite evidence demonstrating improved outcomes when drug counseling is provided along with methadone treatment in opioid treatment programs, no such evidence exists for Bup treatment in primary care. Emerging evidence indicates that PCC physicians offering Bup treatment will likely provide a low level of counseling services, consistent with the minimum requirements under federal regulations, due to fiscal, logistical and competency constraints. Our studies of Bup in primary care demonstrate the feasibility of on-site drug counseling;great variability in Bup adherence and a strong association between improved Bup adherence and improved outcomes;the importance and fragility of early abstinence;and frequent relapse within 6 months even among patients who achieve sustained abstinence during initial 6 months of treatment. To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing Bup adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of Bup in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Bup adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved Bup adherence and will demonstrate incremental cost-effectiveness in patients receiving Bup maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with Bup.
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