Dopamine transporter (DAT) in pharmacological treatments for cocaine addiction - CAIMAN STUDY

INTERVENTION: Trade Name: Modiodal Product Name: Modiodal Pharmaceutical Form: Tablet INN or Proposed INN: modafinil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Cocaine-dependent subjects hospitalized for therapeutic withdrawal. MedDRA version: 8.1 Level: PT Classification code 10001125 Term: substance abuse PRIMARY OUTCOME: Main Objective: Impact of modafinil compared to placebo on changes in DAT density in the striatal and extrastriatal regions of cocaine-dependent subjects hospitalized between days 3 and 21. Primary end point(s): The specific binding rate of [11C]-PE2I to DAT, or binding potential, will be used as a marker of DAT density. The PET images will be integrated and then registered to the individual MRI images to obtain precise individual anatomical localization. Secondary Objective: Evaluation of the clinical efficacy of modafinil in cocaine withdrawal therapy. Correlation between craving measures, depressive symptomatology measures, and observed cognitive deficits and changes in DAT density; Study of DAT on days 3 and 21 compared to a pre-existing control database; Evaluation of the impact of high doses of modafinil on tolerability and safety, measured by adverse events and biological constants. INCLUSION CRITERIA: - Males - Age 18 years or younger and 65 years or younger - Diagnosis of cocaine dependence according to DSM-IV (Structural Clinical Interview for the DSM-IV (SCID)) - Request for treatment for cocaine dependence - Ability to understand and provide informed consent orally and in writing - Affiliation with a social security scheme (beneficiary or dependent) - Completion of a prior medical examination (results to be communicated to the patient) - Positive urine tests for cocaine in the weeks preceding inclusion. 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