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 χ2 = 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.
Key Words
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Article info
Publication history
Published online: July 16, 2012
Accepted:
May 26,
2012
Received in revised form:
May 24,
2012
Received:
February 25,
2012
Identification
Copyright
© 2012 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
