The study, led by Bankole A. Johnson, DSc. MD., MB.ChB., MPhil., chairman of the Department of Psychiatry at the University of Maryland School of Medicine and head of the School's new Brain Science Research Consortium Unit, with support from the National Institutes of Health and Agency for Healthcare Research and Quality, is one of the first to establish a pharmacological treatment for cocaine addiction, for which there are currently no FDA-approved medications.
Addiction affects 13.2 to 19.7 million cocaine users worldwide. Cocaine is responsible for more US emergency room visits than any other illegal drug. Cocaine harms the brain, heart, blood vessels, and lungs-and can even cause sudden death.
Professor Johnson, one of the nation's leading neuroscientists and psychopharmacologists, had previously found that topiramate was a safe and effective treatment for alcohol dependence compared with placebo.
In releasing the new study, Professor Johnson, who conducted the research when he was with Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia, provided full disclosures.
The study enrolled 142 participants, aged 18 years or older, seeking treatment for cocaine dependence.
Following enrollment, participants were randomly assigned into a topiramate group or placebo group.
Neither the participants nor the healthcare professionals administering the treatment knew who was in which group (double-blinded study).
Using an intent-to-treat analysis, the researchers found that topiramate was more efficacious than placebo at increasing the participants' weekly proportion of cocaine nonuse days and in increasing the likelihood that participants would have cocaine-free weeks.
Furthermore, compared with placebo, topiramate also was significantly associated with a decrease in craving for cocaine and an improvement in participants' global functioning.
The study investigators also observed few side effects due to drug treatment.
In general, participants in the topiramate group experienced mild side-effects, including abnormal tingling skin sensations, taste distortions, anorexia, and difficulty concentrating.
The research is published in JAMA Psychiatry.