E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crack-cocaine dependence (according to DSM-IV) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001995 |
E.1.2 | Term | Amphetamine and other psychostimulant dependence |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001996 |
E.1.2 | Term | Amphetamine and other psychostimulant dependence, continuous use |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001997 |
E.1.2 | Term | Amphetamine and other psychostimulant dependence, episodic use |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes are compliance with the study medication, safety, pre- to post-treatment changes in illicit cocaine (and other drug) use, and patient satisfaction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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'). |
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E.4 | Principal exclusion criteria |
(a) severe medical (e.g., severe renal or kidney insufficiency/failure) or psychiatric problems (e.g. acute psychosis, current major depression, suicidal) as well as comorbid heroin dependence, which constitute a contra-indication for participation (b) cardiovascular problems (ECG) (c) pregnancy or continued lactation (d) indication for treatment with naltrexone, disulfiram, or acamprosate (e) anticipated necessity of residential treatment (clinical judgement) (f) insufficient command of the Dutch language (g) current participation in another addiction treatment trial |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Psychosocial Treatment As Usual (Cognitive Behavior Therapy + Motivational Interviewing) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |