Topiramate for cocaine dependence during methadone maintenance treatment: a
randomized controlled trial.
Author(s): Umbricht A(1), DeFulio A(2), Winstanley EL(2), Tompkins DA(2), Peirce J(2),
Mintzer MZ(2), Strain EC(2), Bigelow GE(2).
Affiliation(s): Author information:
(1)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. (2)Behavioral
Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences,
Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224,
USA.
Publication date & source: 2014, Drug Alcohol Depend. , 140:92-100
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).
METHOD: 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.
CONCLUSION: Topiramate is not efficacious for increasing cocaine abstinence in
methadone patients.
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