A second, small clinical trial of a proposed addiction treatment led by investigators at NYU School of Medicine and the U.S. Department of Energy's Brookhaven National Laboratory has produced favorable results in the treatment of long-term addiction to methamphetamine and/or cocaine, with no visual side effects in any of the 30 patients enrolled.
This latest research on GVG (gamma-vinyl GABA), led by Jonathan Brodie, M.D., Ph.D., the Marvin Stern Professor of Psychiatry at NYU School of Medicine and the study's lead author, and Stephen Dewey, Ph.D., of Brookhaven National Laboratory, was conducted at a national addiction treatment center in Mexicali, Mexico. The results are published in the February 2005 issue of Synapse, now available online.
"The fact that this drug appears to be effective in treating addiction to both cocaine and methamphetamine is particularly promising, given that methamphetamine abuse is one of the fastest growing drug problems in this country," said Dr. Brodie.
"We are unaware of any pharmacologic strategy that has been useful in treating methamphetamine dependence, making these findings with GVG unique both in terms of safety and efficacy," said Dr. Brodie. "We expect that the small clinical trials of GVG will lead to larger, placebo-controlled studies of this promising treatment."
Drs. Dewy and Brodie have conducted extensive brain-imaging and behavioral studies on animals showing that GVG attenuates and, in some cases, blocks neurological and behavioral changes associated with drug addiction. Last fall, Drs. Brodie and Dewey published results from the first small-scale human clinical trial of GVG to assess its effects on drug abusers, and showed that it can block cocaine craving in addicts.
GVG is approved for the treatment of epilepsy in many countries, including Mexico, but it is not approved for any indication in the United States in part because some epilepsy patients who have taken cumulative doses in excess of 1500 grams have experienced a reduction in their field of vision. The current study was designed to look for such visual side effects while testing the efficacy of a relatively low GVG dose.
In response to word-of-mouth and newspaper-ad recruitment, 30 patients enrolled in the study. All had abused methamphetamine and/or cocaine daily for a mean duration of 12 years. The experimental design was "open-label," that is, the subjects knew they were getting GVG, an experimental treatment for drug addiction.