Intensive Outpatient v. Outpatient Treatment with Buprenorphine among African Ame

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DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05): Comparative Effectiveness Research, and specific Challenge Topic (05-DA-104): Comparing Drug Treatment Effectiveness in Ethnic Minority Populations Background: Although there is relatively little difference in illicit drug use rates between African Americans and Whites, there is are significant differences in terms of the collateral impact of opiate use on these two communities and wide disparities in their access to treatment. Buprenorphine, a partial mu agonist approved for use the US in 2002 outside of strictly regulated opioid treatment programs, has the potential to reduce the disparity between demand for treatment and treatment access. However it appears from early data on the implementation of buprenorphine in the US that the health disparities faced by African Americans are now extending to this treatment. Indeed, according to SAMHSA over 90 percent of the patients receiving buprenorphine in their evaluation of this treatment were White. Many African Americans in urban areas are unable to find or afford the kind of buprenorphine physician office-based treatment that the approval of buprenorphine was intended to make possible. In Maryland and elsewhere, drug treatment agencies are responding to the disparities in access to buprenorphine treatment by offering grants or contracts to drug treatment programs that have traditionally relied exclusively on psychosocial approaches ("drug-free" outpatient programs) to treatment. This arrangement has potential to ameliorate the access problem for African Americans, who in Baltimore make up about 80 percent of the city's heroin-using population. But this arrangement has also uncovered knowledge gaps that must be filled to enable both access and optimal patient centered treatment for this population. One such gap concerns what level of psychosocial treatment is appropriate for this population. Second, we need to understand how attitudes of staff at formerly abstinence-oriented programs affect the use of an opioid agonist in terms of retention in treatment and outcomes. Design: This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 3 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention. Significance, Innovation and Public Health Impact: This study is significant because it will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large numbers of African Americans, a population with significant need and limited access to this type of effective treatment. Study findings may help to expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the relative benefits of two levels of intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and program retention. The use of the DSM-IV criteria for remission as a one of the outcome measures represents an important augmentation of the usual drug abuse research outcome measures, which usually rely primarily upon urine testing results and self-reports of drug use as the primary outcome measure and do not take into account drug- related reductions in clinically significant impairment or distress, despite some continued intermitted drug use. Public Health Statement This study will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large numbers of African Americans, a population with significant need and limited access to this type of effective treatment which reduces drug use and HIV-risk. Study findings may help to expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the relative benefits of two levels of intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and program retention.