Cocaine dependence and opiate+cocaine dependence are important public health problems. They have proven difficult to treat. Some behavioral approaches are promising, but medications reducing intake, or desire to use drugs will be important treatment adjuncts. Setting conditions can influence outcome. Methadone is an effective medication for opiate dependence. Drugs that act at dopamine pathways either directly or indirectly are reported to alter cocaine intake and other measures in pre-clinical and human studies. Risperidone, may be effective for cocaine dependence. The combination of methadone+ risperidone may be particularly effective in treating concurrent opiate-cocaine dependence. Medication effects, however, will be modulated by optimal setting and behavioral-psychological factors. Visit frequency is a setting condition that we have demonstrated modulates treatment results. Similarly, group and individual treatment are setting conditions for therapy delivery that may alter outcome. Enhancement of behaviorally based 'talk' therapy with contingency management procedures may improve outcome. The proposed studies, like our earlier work, will examine the joint action of behavioral-psychological treatments and medication using logical combinations of these interventions. We propose two sets of three parallel studies. The baseline behavioral- psychological intervention will be a highly structured professionally delivered therapy (2/wk). In Studies 1-3, the cocaine treatment medication will be risperidone (placebo, 4, or 8mg). In Studies 3-6, methadone (approximately 1.1 mg/kg)+risperidone (0, 4, or 8mg) will be administered to opiate+cocaine dependent patients. Risperidone components will be double-blind placebo-controlled. There will be 150 patients in each study randomly assigned but with stratification on some dimensions. Cocaine dependence Studies (1-3) will be 12 weeks and methadone+cocaine dependence Studies (4-6) will be 26 weeks. All studies include self-report, standard medical with HlV and TB tests, and psychiatric evaluations. Phases are consent, intake, 2 week stabilization, treatment, and study end periods, with 3 month follow-up. Major independent variables are medication and dose with setting/treatment variables of visit frequency (2 or 5/week), group vs individual therapy, standard behavioral vs reinforcer enhanced therapy. Major dependent variables are drug use (2/wk urine screens) and retention, with other secondary analyses. The setting/treatment factors have joint actions with medication that can be critical to retention, drug abuse, and reduction of HIV exposure risk. These studies are logical extensions of our ongoing work.
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