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Randomized Controlled Trial
. 2012 Dec 1;72(11):950-6.
doi: 10.1016/j.biopsych.2012.05.032. Epub 2012 Jul 12.

Extended-release mixed amphetamine salts and topiramate for cocaine dependence: a randomized controlled trial

John J Mariani  1 , Martina Pavlicova, Adam Bisaga, Edward V Nunes, Daniel J Brooks, Frances R Levin
Affiliations
Randomized Controlled Trial

Extended-release mixed amphetamine salts and topiramate for cocaine dependence: a randomized controlled trial

John J Mariani et al. Biol Psychiatry. .

Abstract

Background: Cocaine dependence is a substantial public health problem, yet there are no clearly effective medication treatments. Amphetamine and topiramate have both shown promise for the treatment of cocaine dependence in preclinical and early-stage clinical studies.

Methods: Eighty-one cocaine-dependent adults were randomized to receive a combination of extended-release mixed amphetamine salts (MAS-ER) and topiramate or placebo for 12 weeks under double-blind conditions. MAS-ER doses were titrated over 2 weeks to a maximum dose of 60 mg daily, and topiramate doses were titrated over 6 weeks to a maximum dose of 150 mg twice daily. All participants received a supportive behavioral intervention. The primary outcome was the proportion of individuals who achieved 3 consecutive weeks of abstinence as measured by urine toxicology confirmed self-report.

Results: The overall proportion of participants who achieved 3 consecutive weeks of abstinence was larger in the extended-release mixed amphetamine salts and topiramate group (33.3%) than in placebo group (16.7%). There was a significant moderating effect of baseline total number of cocaine use days (Wald χ(2) = 3.75, df = 1, p = .05) on outcome, suggesting that the combination treatment was most effective for participants with a high baseline frequency of cocaine use.

Conclusions: The results of this study supported our hypothesis that the combination of MAS-ER and topiramate would be superior to placebo in achieving 3 weeks of consecutive abstinence. These findings provide evidence that the combination of MAS-ER and topiramate is efficacious in promoting abstinence in cocaine-dependent individuals.

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Figures

Figure 1
Figure 1
CONSORT Flowchart. Participants’ progress through the screening, entry, randomization and medication phases of the treatment trial
See this image and copyright information in PMC

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