Modafinil in the treatment of crack-cocaine dependence in the Netherlands: Results of an open-label randomised controlled feasibility trial.
BACKGROUND
Crack-cocaine dependence is a serious disorder with no approved pharmacological treatment. Modafinil is a promising medication with increased cocaine abstinence and reduced craving in some previous studies. In the present study, we examined the acceptance, safety and potential benefits of modafinil as an add-on treatment to cognitive behavioural therapy (CBT) in crack-cocaine dependent patients.


METHODS
Sixty-five crack-cocaine dependent outpatients participated in an open-label, randomised feasibility trial. Patients were randomised to receive either 12-week individual CBT plus 400 mg/day modafinil or 12-week individual CBT only. The primary outcome measure was CBT treatment retention. Secondary outcomes included modafinil adherence, tolerability and safety, use of cocaine and other substances, cocaine craving, health, social functioning and patient satisfaction.


RESULTS
Modafinil adherence was low, with only 10% treatment completers. Intent-to-treat analyses showed that modafinil did not improve CBT treatment retention or any of the secondary cocaine-related outcomes. Both groups showed similar, large reductions in cocaine use during the study treatment. Post hoc exploratory analyses within the CBT plus modafinil group showed significantly larger baseline to week 12 reductions in cocaine use days in high (⩾ 8 weeks) modafinil adherent patients.


CONCLUSIONS
Acceptance and benefits of modafinil were not demonstrated in the present study. Since reduction in cocaine use was observed in high modafinil adherent patients, further research in the treatment of cocaine dependence, in which modafinil adherence is optimised, is warranted.
Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), The Hague, the Netherlands mascha.nuijten@brijder.nl.
Mascha
M
Nuijten
Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), The Hague, the Netherlands.
Peter
P
Blanken
Amsterdam Institute for Addiction Research, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Wim
W
van den Brink
Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), The Hague, the Netherlands.
Vincent
V
Hendriks
D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods; D016578:Crack Cocaine / Q000009:adverse effects*; D065701:Cytochrome P-450 CYP3A Inducers / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009426:Netherlands; D010349:Patient Compliance; D017060:Patient Satisfaction; D016896:Treatment Outcome
D001559:Benzhydryl Compounds; D016578:Crack Cocaine; D065701:Cytochrome P-450 CYP3A Inducers; D000077408:Modafinil
Modafinil; cocaine dependence; crack-cocaine dependence; medication adherence; randomised controlled trial; treatment retention