Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Proposed Addiction Treatment Successful, Safe in Second Small Trial

16.11.2004


Prolonged abstinence, no visual problems in patients taking GVG for meth/cocaine abuse



A second, small-scale clinical trial of a proposed addiction treatment originally investigated at 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 research on vigabatrin (a.k.a. gamma vinyl GABA, or GVG) was conducted in collaboration with doctors from the New York University (NYU) School of Medicine and the Nathan Kline Institute for Psychiatric Research at a national addiction treatment center in Mexicali, Mexico. The results are published in the February 2005 issue of Synapse, now available online.

“We now have additional clinical data to back up our belief that GVG can be used safely and effectively to treat people suffering from drug addiction,” said Brookhaven neuroanatomist Stephen Dewey. Dewey and Jonathan Brodie, a professor of psychiatry at NYU School of Medicine and this study’s lead author, have conducted extensive brain-imaging and behavioral studies on animals at Brookhaven Lab showing that GVG attenuates and in some cases blocks neurological and behavioral changes associated with drug addiction. Last fall, they published results from the first small-scale human clinical trial of GVG for this indication, showing it to be effective in treating cocaine addiction. “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,” Brodie said.


These results, especially given the absence of visual side effects in all patients, bring the scientists closer to seeing GVG tested in a larger, placebo-controlled clinical trial in this country.

GVG is approved for the treatment of epilepsy in many countries, including Mexico, but it is not approved for any indication in the U.S., 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. During the first two weeks, they were given increasing doses to a maximum of three grams per day, and then maintained on that dose for 28 days before tapering back to zero over the final three weeks.

They were treated as outpatients, returning each day to their normal home environments, subject to all the environmental “triggers” for their addictive behavior. Twice weekly they gave urine samples, which were tested for cocaine, methamphetamine, marijuana, heroin, and alcohol. Visual tests were performed on all 30 subjects prior to, during, and after completion of the trial.

Of the 30 volunteers, 11 dropped out in the first four weeks. One subject completed eight weeks and 18 stayed in the study for the nine-week duration. Of those 18, 16 were methamphetamine- and cocaine-free for more than four consecutive weeks while two continued using but in reduced amounts. 12 of the 16 remained free of methamphetamine and cocaine through the end of the study. No subject, whether they completed the trial or not, developed defects in visual fields or acuity. “Due to the open-label nature of this study and the lack of a control group, we cannot conclude that these subjects’ ability to abstain from drug use was a direct result of being given GVG. However, in a group of heavy users where none had stayed ‘clean’ for more than several consecutive days in the past year, it is remarkable that 16 of 30 avoided using these highly addictive drugs for approximately four consecutive weeks while on GVG,” Dewey said.

“Of course, the conclusive demonstration of treatment efficacy can only be provided by an appropriately blinded randomized study, where some patients are given GVG and others a placebo, and neither the researchers nor the subjects know which is which until after the results are analyzed,” said Brodie.

With the lack of visual side effects observed for the doses used in this study — a factor that has been viewed as an impediment to getting GVG approved in the U.S. — the scientists hope to see such a large-scale study conducted soon. “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,” Brodie said.

This research was funded by the Biochemical Psychiatry Fund at the NYU School of Medicine; Catalyst Pharmaceutical Partners (CPP*) of Coral Gables, Florida; the National Institute on Drug Abuse; and the Office of Biological and Environmental Research within the U.S. Department of Energy’s Office of Science.

*In October 2002, CPP received an exclusive worldwide license from Brookhaven Science Associates, operator of Brookhaven Lab, for the use of GVG for its application in treating drug addiction.

Karen McNulty Walsh | EurekAlert!
Further information:
http://www.bnl.gov

More articles from Health and Medicine:

nachricht Why might reading make myopic?
18.07.2018 | Universitätsklinikum Tübingen

nachricht Unique brain 'fingerprint' can predict drug effectiveness
11.07.2018 | McGill University

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: First evidence on the source of extragalactic particles

For the first time ever, scientists have determined the cosmic origin of highest-energy neutrinos. A research group led by IceCube scientist Elisa Resconi, spokesperson of the Collaborative Research Center SFB1258 at the Technical University of Munich (TUM), provides an important piece of evidence that the particles detected by the IceCube neutrino telescope at the South Pole originate from a galaxy four billion light-years away from Earth.

To rule out other origins with certainty, the team led by neutrino physicist Elisa Resconi from the Technical University of Munich and multi-wavelength...

Im Focus: Magnetic vortices: Two independent magnetic skyrmion phases discovered in a single material

For the first time a team of researchers have discovered two different phases of magnetic skyrmions in a single material. Physicists of the Technical Universities of Munich and Dresden and the University of Cologne can now better study and understand the properties of these magnetic structures, which are important for both basic research and applications.

Whirlpools are an everyday experience in a bath tub: When the water is drained a circular vortex is formed. Typically, such whirls are rather stable. Similar...

Im Focus: Breaking the bond: To take part or not?

Physicists working with Roland Wester at the University of Innsbruck have investigated if and how chemical reactions can be influenced by targeted vibrational excitation of the reactants. They were able to demonstrate that excitation with a laser beam does not affect the efficiency of a chemical exchange reaction and that the excited molecular group acts only as a spectator in the reaction.

A frequently used reaction in organic chemistry is nucleophilic substitution. It plays, for example, an important role in in the synthesis of new chemical...

Im Focus: New 2D Spectroscopy Methods

Optical spectroscopy allows investigating the energy structure and dynamic properties of complex quantum systems. Researchers from the University of Würzburg present two new approaches of coherent two-dimensional spectroscopy.

"Put an excitation into the system and observe how it evolves." According to physicist Professor Tobias Brixner, this is the credo of optical spectroscopy....

Im Focus: Chemical reactions in the light of ultrashort X-ray pulses from free-electron lasers

Ultra-short, high-intensity X-ray flashes open the door to the foundations of chemical reactions. Free-electron lasers generate these kinds of pulses, but there is a catch: the pulses vary in duration and energy. An international research team has now presented a solution: Using a ring of 16 detectors and a circularly polarized laser beam, they can determine both factors with attosecond accuracy.

Free-electron lasers (FELs) generate extremely short and intense X-ray flashes. Researchers can use these flashes to resolve structures with diameters on the...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Leading experts in Diabetes, Metabolism and Biomedical Engineering discuss Precision Medicine

13.07.2018 | Event News

Conference on Laser Polishing – LaP: Fine Tuning for Surfaces

12.07.2018 | Event News

11th European Wood-based Panel Symposium 2018: Meeting point for the wood-based materials industry

03.07.2018 | Event News

 
Latest News

NYSCF researchers develop novel bioengineering technique for personalized bone grafts

18.07.2018 | Life Sciences

Machine-learning predicted a superhard and high-energy-density tungsten nitride

18.07.2018 | Materials Sciences

Why might reading make myopic?

18.07.2018 | Health and Medicine

VideoLinks
Science & Research
Overview of more VideoLinks >>>