title: Treatment of crack-cocaine dependence with topiramate: a randomized controlled feasibility trial in The Netherlands.
abstract: BACKGROUND
  Crack-cocaine dependence is a complex disorder with limited treatment options. Topiramate is one of the promising medications with reported reductions in cocaine use and craving in former studies. The present study evaluated the acceptance and effectiveness of topiramate as an add-on to cognitive behavioral therapy (CBT) in crack-cocaine dependent patients.
  
  
  METHODS
  Seventy-four crack-cocaine dependent outpatients participated in an open-label, randomized feasibility trial. They were randomized to receive either 12-week CBT plus topiramate (200mg/day) or 12-week CBT only. The primary outcome measure was treatment retention. Secondary outcomes included medication adherence, safety, cocaine and other substance use, health, social functioning, and patient satisfaction.
  
  
  RESULTS
  Adherence to topiramate treatment was low. In the intent-to-treat analyses, topiramate neither improved treatment retention nor reduced cocaine and other substance use. Post hoc, exploratory analyses suggested a moderation effect of comorbid opioid dependence, with a significant effect of topiramate on cocaine use reduction only in crack-cocaine dependent patients with comorbid opioid dependence.
  
  
  CONCLUSIONS
  Topiramate was safe and well-tolerated in this sample of crack-cocaine dependent patients, but efficacy was not supported probably due to low acceptance of the treatment. Given the equivocal results of previous studies and the negative findings in our study, the potential of topiramate in the treatment of cocaine dependence seems limited.
authors.affiliation: Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), PO Box 53002, 2505 AA The Hague, The Netherlands. Electronic address: mascha.nuijten@brijder.nl.
authors.forename: Mascha
authors.initials: M
authors.lastname: Nuijten
authors.affiliation: Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), PO Box 53002, 2505 AA The Hague, The Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: Blanken
authors.affiliation: Amsterdam Institute for Addiction Research, Department of Psychiatry, Academic Medical Centre, University of Amsterdam, PO Box 22660, 1100 DD Amsterdam, The Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: van den Brink
authors.affiliation: Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), PO Box 53002, 2505 AA The Hague, The Netherlands.
authors.forename: Vincent
authors.initials: V
authors.lastname: Hendriks
mesh_terms: D000328:Adult; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000628:therapy; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D016578:Crack Cocaine; D005240:Feasibility Studies; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D055118:Medication Adherence; D009426:Netherlands; D010349:Patient Compliance; D017060:Patient Satisfaction; D012919:Social Behavior; D000077236:Topiramate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016578:Crack Cocaine; D000077236:Topiramate; D005632:Fructose
keywords: Crack-cocaine dependence; Medication adherence; RCT; Topiramate; Treatment retention