Dr. Abrams' FDA-approved protocol is for a pilot project that calls for 40 volunteers with a clinical diagnosis of the AIDS Wasting Syndrome. Subjects will be randomly assigned to one of four groups, each composed of ten people. The subjects in one group will receive up to 2 grams daily of high potency marijuana (10% THC), another medium potency (4% THC), and another low potency (1.5% THC). The fourth group will receive oral THC capsules (marinol). The study will last for a period of three months, with the primary outcome variable being each subject's weight. If a statistically significant difference in weight gain is demonstrated between the subjects in the different groups, then the next step will be to perform a larger scale, multi-site study designed to be of sufficient size to generate statistically significant conclusions.
Given the DEA's refusal to move marijuana to Schedule II (prescription availability), and the subsequent ruling of the United States Court of Appeals (D.C. Circuit) in February 1994, supporting the DEA's position, further progress would have to come from President Clinton, Attorney General Reno, Congress, or the FDA. Although Congressman Barney Frank has promised to file medical marijuana legislation this year, chances seem slim that such a bill would make it through in the current political climate. The Clinton administration has adopted a position focusing on the lack of FDA-approved research into the medical use of marijuana. Fortunately, the FDA is willing to work on moving the issue forward, at least at this stage.
The information in this article was extracted from the newsletter of the Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that is sponsoring Dr. Abrams' study and helping him work through the recalcitrant bureaucracy standing in his way. General membership in MAPS is $30/year (outside US add $15). MAPS can be reached at:
Multidisciplinary Association for Psychedelic Studies (MAPS)
2121 Commonwealth Ave., Suite 220-A
Charlotte, NC 28205, USA
Rick Doblin, President
Sylvia Thyssen, Networks Coordinator
voice: (704) 334-1798
fax: (704) 334-1799
E-mail: [email protected]
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