Extended-release mixed amphetamine salts and topiramate for cocaine dependence: a randomized controlled trial.
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.
Division of Substance Abuse, New York State Psychiatric Institute, New York 10032, USA.
John J
JJ
Mariani
Martina
M
Pavlicova
Adam
A
Bisaga
Edward V
EV
Nunes
Daniel J
DJ
Brooks
Frances R
FR
Levin
D000293:Adolescent; D000328:Adult; D000661:Amphetamine / Q000008:administration & dosage / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D057566:Self Report; D000077236:Topiramate; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D004338:Drug Combinations; D000077236:Topiramate; D005632:Fructose; D000661:Amphetamine