A partial blockade of the multiple actions of cocaine is one strategy by which cocaine dependence may be treated. Risperidone, a 5-hydroxytryptamine and dopamine D2 antagonist, is an atypical antipsychotic and was a candidate medication for the treatment of cocaine dependence. One hundred ninety-three cocaine-dependent subjects were enrolled in a 12-week, randomized, double-blind, placebo-controlled trial. Subjects initially received either placebo or 4 or 8 mg of risperidone, with a subsequent change to active doses of 2 mg and 4 mg. Subjects attended the clinic twice each week, provided urine samples, obtained medication, and underwent one behavioral therapy session per week. The study was terminated at the interim analysis. Retention was worse for the 4- and 8-mg active medication groups. Side effects were primarily associated with the 8-mg dose, although neither 2 mg nor 4 mg was well accepted by subjects. There was no reduction in cocaine use associated with risperidone. The results suggest that although antagonists might be a useful treatment approach, such as in the treatment of opiate dependence, risperidone is unlikely to find broad acceptance with the treatment-seeking population.
El abuso simultáneo de cocaína y la heroína es un problema común. La metadona es eficaz para la dependencia de opiáceos. La pregunta que surge es si la combinación de agonista o antagonista-como-al igual que medicamentos para la cocaína con metadona para la dependencia de opiáceos podría ser eficaz. Dos estudios se realizaron en paralelo. Uno examinó la liberación sostenida de d-anfetamina y la risperidona otra dependencia de la cocaína, cada uno en combinación con la metadona. En total, 240 sujetos (120/study) fueron contratados, que eran cocaína y heroína dependientes y no están recibiendo medicación. Todos dieron su consentimiento. Ambos estudios se llevaron a cabo durante 26 semanas, aleatorizado, doble ciego y controlado con placebo. Estudio I en comparación liberación sostenida la d-anfetamina (escalada de 15-30 mg o de 30 a 60) y el placebo. Estudio II examinó con risperidona (2 mg o 4) y el placebo. Todos los sujetos se sometieron a la inducción de la metadona y se estabilizó en 1,1 mg / kg. Los sujetos asistieron a la clínica dos veces / semana, proporcionaron muestras de orina, medicamentos obtenidos para llevar a casa las dosis para los días intermedios, y completó las medidas de auto-reporte. Cada uno tenía una sesión de terapia de comportamiento / semana. En el Estudio I, la reducción del consumo de cocaína fue significativa para la dosis de 30/60 mg en comparación con el de 15 mg / 30 y el placebo. Consumo de opiáceos se ha reducido en todos los grupos con una tendencia hacia una mayor reducción en el 30/60 mg de d-anfetamina grupo. En el Ensayo II, con metadona redujo el consumo ilegal de opiáceos, pero el consumo de cocaína no ha cambiado en la risperidona o placebo. No hubo interacciones medicamentosas adversas en ninguno de los estudios. Los resultados proporcionan apoyo para el agonista-como (d-anfetamina) el modelo en el tratamiento de la dependencia de cocaína, pero no para el antagonista-como (risperidona) de tratamiento. Ellos coinciden con los informes anteriores de la anfetamina o la risperidona administrada individualmente en las personas dependientes de la cocaína.
A partial blockade of the multiple actions of cocaine is one strategy by which cocaine dependence may be treated. Risperidone, a 5-hydroxytryptamine and dopamine D2 antagonist, is an atypical antipsychotic and was a candidate medication for the treatment of cocaine dependence. One hundred ninety-three cocaine-dependent subjects were enrolled in a 12-week, randomized, double-blind, placebo-controlled trial. Subjects initially received either placebo or 4 or 8 mg of risperidone, with a subsequent change to active doses of 2 mg and 4 mg. Subjects attended the clinic twice each week, provided urine samples, obtained medication, and underwent one behavioral therapy session per week. The study was terminated at the interim analysis. Retention was worse for the 4- and 8-mg active medication groups. Side effects were primarily associated with the 8-mg dose, although neither 2 mg nor 4 mg was well accepted by subjects. There was no reduction in cocaine use associated with risperidone. The results suggest that although antagonists might be a useful treatment approach, such as in the treatment of opiate dependence, risperidone is unlikely to find broad acceptance with the treatment-seeking population.