Optimizing Outcomes Using Suboxone for Opiate Dependence (R01 DA 020210-01)

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DESCRIPTION (provided by applicant): The approval of buprenorphine (combined with naloxone as Suboxone(r)) by the FDA enables physicians in the United States to provide pharmacotherapy to opioid-dependent patients in private medical settings. Buprenorphine's wide acceptance and implementation by physicians has been slower than expected, however, and this may be due in part to the nature and necessity of providing comprehensive treatment for opioid-dependent patients. Lessons learned from methadone maintenance make it clear that simply providing opioid substitution does not address the behavioral components of dependence. While there is no lack of behavioral treatment facilities for substance abuse in the United States, what is lacking is an integrative approach to the treatment of opioid dependence using pharmacotherapy in conjunction with empirically based behavioral treatment strategies. This project will evaluate the added therapeutic effects of three specific behavioral strategies, delivered in the context of a basic medical management (med mgmt) platform approaching what physicians do, in general, when prescribing buprenorphine. Two-hundred forty (240) participants will be randomly assigned after a two week stabilization to one of four groups: (1) cognitive behavioral therapy (CBT/med mgmt; n=60) emphasizing relapse prevention, (2) contingency management (CM/med mgmt; n=60) providing incentives for successive opioid-free urine tests, (3) a combined group containing both CBT and CM (CBT+CM/med mgmt; n=60), and (4) med mgmt only (neither CBT nor CM; n=60). Experimental behavioral therapies will be delivered for 16 weeks (to study week 18) in conjunction with Suboxone(r) pharmacotherapy. An additional 16 weeks of treatment using Suboxone(r) (to study week 34) will ensue during which no experimental behavioral therapies are provided. All participants enter a buprenorphine taper and return at study week 52 for long-term follow-up evaluations. Outcomes for the trial include illicit drug use (urine drug samples collected three times per week during the first 18 weeks), drug craving, retention (days in the protocol), psychiatric status (depression, mood), HIV-risk behaviors, and treatment feasibility ratings. Results will be used to recommend strategies to optimize buprenorphine treatment outcomes and promote integration of pharmacotherapy and psychosocial/behavioral treatment strategies for physicians and for behavioral treatment facilities treating opioid-dependent patients.