New pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands.

INTERVENTION: Trade Name: Modiodal Pharmaceutical Form: Tablet Trade Name: Topamax Pharmaceutical Form: Tablet Trade Name: Adderal XR Pharmaceutical Form: Capsule* CONDITION: Crack‐cocaine dependence (according to DSM‐IV) ; MedDRA version: 9.1 Level: LLT Classification code 10001995 Term: Amphetamine and other psychostimulant dependence ; MedDRA version: 9.1 Level: LLT Classification code 10001996 Term: Amphetamine and other psychostimulant dependence, continuous use ; MedDRA version: 9.1 Level: LLT Classification code 10001997 Term: Amphetamine and other psychostimulant dependence, episodic use PRIMARY OUTCOME: Main Objective: The study consists of three randomised controlled feasibility trials, conducted according to a pre‐randomisation, double‐consent design. A random selection of the eligible patients in addiction treatment will be invited to receive 12 weeks of treatment with one of the following medications: oral topiramate (n=36), oral modafinil (n=36), and oral dexamphetamine SR (n=36), as an add‐on to outpatient psycho‐social treatment‐as‐usual (TAU). The remaining eligible patients will constitute the control groups (n=36 for each medication study), and will receive TAU alone. Primary outcomes in these feasibility trials are acceptance and treatment retention. Primary end point(s): The study data will be analysed following an intent‐to‐treat (ITT) approach. The ITT‐population consists of all randomised patients who received at least one dose of the prescribed medication (medication groups), or at least one session of TAU (control groups). Effect of the interventions will be evaluated in terms of treatment retention, compliance, illicit cocaine use (self‐report; urinalyses), cocaine craving, use of other substances, physical and mental health, social functioning (including criminality), and patient satisfaction. The primary outcome measure is treatment retention during the 12‐weeks study period, defined as the number of weeks attended following the start of treatment Secondary Objective: Secondary outcomes are compliance with the study medication, safety, pre‐ to post‐treatment changes in illicit cocaine (and other drug) use, and patient satisfaction. INCLUSION CRITERIA: (a) at least 18 years old (b) cocaine dependence (DSM‐IV) during at least the previous year (c) cocaine use on a regular basis (i.e., = 8 days) in the previous month (d) administer cocaine primarily by means of basing ('crack') (e) able and willing to participate in outpatient psycho‐social treatment and associated assessments (control condition), or be able and willing to participate in outpatient psycho‐social treatment supplemented with the study medication and associated assessments (experimental condition) (f) have provided written informed consent with regard to their assigned study treatment In the sub‐study with dexamphetamine SR, the minimal duration of cocaine dependency will be five years instead of one year. In addition, patients have to meet one extra inclusion criterion: (g) a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment‐refractory'). Are the trial subjects under 18? no