For Release September 22, 2003

A preliminary clinical trial funded by the National Institute on Drug Abuse, the National Institutes of Health, suggests that gamma vinyl-GABA (GVG) - a drug used to treat epilepsy - may offer a potentially effective treatment for cocaine addiction.

Researchers from New York University School of Medicine and Brookhaven National Laboratory in Upton, New York, report this week in the online version of the journal Synapse that a small, preliminary clinical trial conducted in Mexico showed this drug could cut cocaine use dramatically in people who had used cocaine daily for at least 3 years.

The data reported in this study support the need for a larger, double-blind, placebo-controlled trial to determine the true efficacy and safety of this drug for cocaine addiction, the authors say.

"GVG reduces levels of dopamine, the 'feel-good' chemical that floods the brains of cocaine users, providing the 'high' they crave," says Dr. Frank Vocci, Director, Division of Treatment Research and Development, National Institute on Drug Abuse. "Using GVG to temper the dopamine system may very effectively block the addiction-related effects of cocaine."

A total of 19 men and 1 woman entered the study. Eight people completed the trial in which they received escalating doses of GVG for the first week until they reached the highest dose of 4 grams per day. "At the time the paper was written these eight people had remained drug free for 46-58 days," notes Dr. Jonathan Brodie, the Marvin Stern professor of psychiatry at NYU and lead author of the study. "All eight of these subjects have remained clean for at least another 4 weeks despite no longer being on GVG and have indicated that craving has not returned," he adds. "Hence, they have all been drug free for a minimum of 74 days and counting."

"This preliminary finding has important implications for our medications development program," says NIDA Director Dr. Nora D. Volkow.

The eight people who completed the study said their craving for the drug was eliminated after 2-3 weeks of continuous GVG administration, the authors report. In addition, those who completed the trial also showed improved self-esteem, reestablished healthy family relationships, went to work, or actively sought work.

GVG, also known as vigabatrin, is approved in many countries as a treatment for epilepsy. Its main effect is that it increases the amount of another brain chemical involved in nerve cell communication, GABA, and thus helps moderate seizures. The U.S. Food and Drug Administration has not approved GVG for treating epilepsy or any indication because of concerns about the relatively high incidence of tunnel vision that has occurred in people given the drug over many months or years. Although none of the eight people who completed this study reported vision changes, the effects of vigabatrin on the eye have been of sufficient concern to relegate it to second-line status in countries where it is marketed, and to prompt the requirement of regular follow-up by an ophthalmologist.

"Cocaine addiction represents a disease process for which there is no recognized effective drug treatment," says Dr. Brodie. "Now, for the first time, there is compelling human data that supports the efficacy of a drug for this problem."

The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports more than 85 percent of the world's research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to ensure the rapid dissemination of research information and its implementation in policy and practice. Fact sheets on the health effects of drugs of abuse and further information on NIDA research can be found on the NIDA web site at http://www.drugabuse.gov.