Estudio de la eficacia de la cafeína en el tratamiento de mantenimiento de pacientes con dependencia de cocaína - CAF-MT

INTERVENTION: Trade Name: Durvitan Product Name: caffeine Pharmaceutical Form: Capsule* INN or Proposed INN: caffeine Other descriptive name: 1,3,7‐trimetilxantina Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50,100,200,300‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Akineton retard Product Name: Akineton Retard Product Code: 51224 Pharmaceutical Form: Capsule* INN or Proposed INN: biperiden Other descriptive name: alfa‐2‐biciclo[2.2.1]hept‐5‐en‐2‐il‐a‐fenil‐1‐piperidinopropam¡nolol Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: COCAINE DEPENDENCE PRIMARY OUTCOME: Main Objective: to assess the efficacy of caffeine with or without biperidene as a maintence treatment for cocaine dependent patients according to DSM‐IV‐TR criteria. Primary end point(s): Study retention.; Craving for cocaine.; Cocaine use. Secondary Objective: to assess the toxicity of caffeine with or without biperidene as a maintence treatment for cocaine dependent patients according to DSM‐IV‐TR criteria.; ; to assess the influence of cyp1A2 phenotypes on the efficay and the toxicity of caffeine with or without biperidene as a maintence treatment for cocaine dependent patients according to DSM‐IV‐TR criteria. INCLUSION CRITERIA: 1. Dependencia de cocaína, según criterios DSM‐IV‐TR, en la actualidad. 2. Edad superior o igual a los 18 años e igual o inferior a los 60 años. 3. La presencia de consumo activo de cocaína, confirmado con un urinoanálisis positivo a esta sustancia, en las 2 semanas previas a la inducción del tratamiento. 4. Capacidad suficientemente comprobada para otorgar y firmar el correspondiente consentimiento informado. 5. Lugar de residencia habitual compatible con la asistencia al centro. 6. En caso de ser mujer, tomar medidas anticonceptivas de barrera eficaces. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range