Cocaine dependence Crack cocaine RCT Topiramate Modafinil Dexamphetamine SR Psychosocial treatment
Conditions
Interventions
Psychosocial treatment (treatment as usual
TAU) compared with TAU added with experimental medication.
The intervention will study the effect of Topiramate, Dexamphetamine and Modafinil, as an add-on to a weekly outpatient psychosocial treatme
Sponsors
Academic Medical Centre, Amsterdam, the Netherlands. Brijder Verslavingszorg (The Hague: 1 study site), BoumanGGZ/Antes (Rotterdam: 1 study site), and GGD Amsterdam (Amsterdam: 2 study sites).
Eligibility
Inclusion criteria
Inclusion criteria: In the sub-studies of topiramate and modafinil, eligible patients must: 1. Be at least 18 years old; 2. Be cocaine dependent (DSM-IV) during at least the previous year; 3. Use cocaine on a regular basis (i.e., >= 8 days) in the previous month; 4. Administer their illicit cocaine primarily by means of basing ('crack'); 5. Be able and willing to participate in outpatient psycho-social treatment and associated assessments; 6. 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, these patients have to meet one extra inclusion criterion: 7. A history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory').
Exclusion criteria
Exclusion criteria: Patients will be excluded in case of: 1. Severe medical (e.g., severe renal or kidney insufficiency/failure) or psychiatric problems (e.g. acute psychosis, current major depression, suicidal), which constitute a contra-indication for participation; 2. Cardiovascular problems (ECG); 3. Pregnancy or continued lactation; 4. Indication for treatment with naltrexone, disulfiram, or acamprosate; 5. Anticipated necessity of residential treatment (clinical judgement); 6. Insufficient command of the Dutch language; 7. Current participation in another addiction treatment trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data will be analysed following an intention-to-treat approach, consisting of all randomised patients that received TAU with at least one dose of the prescribed medication (experimental groups) or TAU only (control groups). The primary outcome measure is treatment retention, defined as the number of weeks attended following the start of treatment. In each sub-study, the treatment groups will be compared on length of treatment until dropping out or termination, using a Cox proportional hazards regression model. Compliance with the study medication can only be investigated in the experimental conditions. Changes 04-04-2016: The primary outcome measure is defined as cocaine use, defined as the total number of days of crack-cocaine use during the 12 weeks study period (range: 0 – 84 days), and will be analyzed in a multivariate regression analysis, controlling for study group and treatment site interactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effects of the interventions will be evaluated in terms of safety, illicit cocaine use, cocaine craving, use of other substances, physical and mental health, social functioning (including criminality), and patient satisfaction. Pre- to post-treatment changes in illicit cocaine use, defined as the number of illicit cocaine using days in the month preceding the assessment, will be compared between the two study groups in each sub-study using a 2 (time) x 2 (group) repeated measures ANOVA. Similar analyses will be conducted for changes in substance use other than cocaine, and for other continuous and Likert-scaled outcome measures. | — |
Contacts
Public ContactMascha Nuijten
Parnassia Addiction Research Centre (PARC) Monsterseweg 83
Outcome results
None listed