In December, 1992, the FDA approved the oral THC pill for prescription use in stimulating appetite and reducing weight loss associated with the HIV-related wasting syndrome. However, numerous patients and physicians believe that smoked marijuana is a much better medicine than the oral THC pill. Some reasons cited in support of smoked marijuana's claimed superiority are its more rapid and reliable absorption in the body as compared to oral THC, as well to the variety of cannabinoids (ingredients chemically related to THC) that are present in the marijuana plant but absent from the THC pill.
MAPS intends to help resolve the controversy over the medical use of marijuana by working to facilitate a scientific pilot study comparing the safety and efficacy of smoked marijuana to the oral THC pill in treating the wasting syndrome. The study will be directed by Dr. Donald Abrams, a faculty member at the University of California San Francisco and the research director of the AIDS Consortium.
The study will involve 60 subjects, 30 in the smoked marijuana group and 30 in the oral THC group. Each subject will take the study drug for a period of three months, during which their weight will be monitored on a monthly basis. Subjects will also be monitored for a wide range of side effects as well as for various quality of life issues. At the end of the study period, an average weight difference of more than three kilograms between the two groups will be considered clinically significant. If the study demonstrates smoked marijuana's superiority, a larger multi-site study (hopefully funded by the government) will need to be conducted to see if the results can be replicated.
In order to minimize the potentially deleterious effects of marijuana smoke in AIDS patients, MAPS is seeking to design and test a water pipe for possible use in this study. In addition, MAPS is working to secure permission to import high-THC content marijuana (10% THC) from the Netherlands for the study rather than accept the low-THC content marijuana (2 or 3% THC) available from the National Institute on Drug Abuse. Obviously, the higher the THC content of the marijuana, the less smoke that patients will need to inhale per dose of THC and related compounds. Roxanne, Inc., the company that markets the THC pill, has generously offered to donate all the pills required for the research project.
This protocol is nearing the end of the design phase (several months after the too optimistic timetable I reported in the last MAPS newsletter) and a final budget will be drawn up soon. My working estimate for the entire study (based on the Consortium's rule of thumb that studies cost about $2,000 per subject) is $120,000. MAPS has received a pledge of $50,000 for this study from an individual in the Netherlands. I will not actually request that the $50,000 be contributed until the experiment has been approved by all the required authorities and the remaining funds have been pledged.
My current hope is that the study will begin in late 1993.