This Mentored Patient-Oriented Research Career Development Award (RCA--K23) application will support the career development of the candidate to become a clinical trials interventionist for substance abuse treatments with an emphasis on treatments appropriate for communities of color. Dr. Robert L. Hubbard of Duke University Medical Center and Duke Clinical Research Institute will be the primary mentor. The candidate will adapt the Community Reinforcement Approach (CRA), an efficacious treatment for cocaine dependence, for a difficult-to-treat group: Black parenting cocaine dependent women. In Study Phase I, Standard CRA will be modified based on recommendations from the available maternal treatment literature, interviews with clients and clinic staff and two small open pilot tests of Modified CRA. In Study Phase II, Modified CRA will be tested for feasibility and efficacy in a single blind, randomized clinical trial. Fifty participants will be randomized to Modified CRA or Treatment as Usual in an outpatient comprehensive Family Care Program. The primary endpoint will be retention--the proportion of participants retained for 12 weeks of treatment. The secondary endpoint will be abstinence--the proportion of urine samples negative for cocaine metabolite (benzoylecognine). This RCT will also (1) generate effect sizes for future effectiveness trials of Modified CRA for Black parenting cocaine dependent women and 2) result in supplemental appendices that detail translational and technology transfer issues in the implementation of Modified CRA in a woman-focused outpatient community treatment setting. The career training plan hinges on an advanced Masters Program in Clinical Trials at the Duke Clinical Research Institute and a set of coordinated mentorships in clinical trials, technology transfer, and culturally relevant treatment approaches for substance related disorders. Related career development activities will include leadership and participation in NIDA Clinical Trials Network protocols, publications of survey data assessing the needs of maternal populations, and participation in minority career development seminars at the Center for AIDS Prevention Research in San Francisco, and at Duke University Medical Center. The research and didactic elements of this K23 in hand, the applicant will emerge as an independent investigator capable of designing and implementing clinical interventions to improve substance abuse treatments not only for Black parenting women but for difficult-to-treat communities of color.
