title: Topiramate for cocaine dependence during methadone maintenance treatment: a randomized controlled trial.
abstract: BACKGROUND
  Dual dependence on opiate and cocaine occurs in about 60% of patients admitted to methadone maintenance and negatively impacts prognosis (Kosten et al. 2003. Drug Alcohol Depend. 70, 315). Topiramate (TOP) is an antiepileptic drug that may have utility in the treatment of cocaine dependence because it enhances the GABAergic system, antagonizes the glutamatergic system, and has been identified by NIDA as one of only a few medications providing a "positive signal" warranting further clinical investigation. (Vocci and Ling, 2005. Pharmacol. Ther. 108, 94).
  
  
  METHODS
  In this double-blind controlled clinical trial, cocaine dependent methadone maintenance patients (N=171) were randomly assigned to one of four groups. Under a factorial design, participants received either TOP or placebo, and monetary voucher incentives that were either contingent (CM) or non-contingent (Non-CM) on drug abstinence. TOP participants were inducted onto TOP over 7 weeks, stabilized for 8 weeks at 300 mg daily then tapered over 3 weeks. Voucher incentives were supplied for 12 weeks, starting during the fourth week of TOP induction. Primary outcome measures were cocaine abstinence (Y/N) as measured by thrice weekly urinalysis and analyzed using Generalized Estimating Equations (GEE) and treatment retention. All analyses were intent to treat and included the 12-week evaluation phase of combined TOP/P treatment and voucher intervention period.
  
  
  RESULTS
  There was no significant difference in cocaine abstinence between the TOP vs. P conditions nor between the CM vs. Non-CM conditions. There was no significant TOP/CM interaction. Retention was not significantly different between the groups.
  
  
  CONCLUSIONS
  Topiramate is not efficacious for increasing cocaine abstinence in methadone patients.
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA. Electronic address: annieumbricht@jhu.edu.
authors.forename: Annie
authors.initials: A
authors.lastname: Umbricht
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: DeFulio
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: Erin L
authors.initials: EL
authors.lastname: Winstanley
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: D Andrew
authors.initials: DA
authors.lastname: Tompkins
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Peirce
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: Miriam Z
authors.initials: MZ
authors.lastname: Mintzer
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: Eric C
authors.initials: EC
authors.lastname: Strain
authors.affiliation: Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
authors.forename: George E
authors.initials: GE
authors.lastname: Bigelow
mesh_terms: D000293:Adolescent; D000328:Adult; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D008875:Middle Aged; D009294:Narcotics / Q000627:therapeutic use*; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment / Q000379:methods*; D010349:Patient Compliance; D015813:Substance Abuse Detection; D000077236:Topiramate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009294:Narcotics; D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose; D008691:Methadone
keywords: Antiepileptic; Cocaine dependence; Contingency Management; GABA; Glutamate; Topiramate