INVESTIGATOR: Dennis Israelski, M.D.
STUDY LOCATION: San Mateo Medical Center
PROJECT TITLE: MMJ for HIV-associated DSPN: Adherence & Compliance Sub-Study
PROJECT TYPE: Clinical Sub-Study
Recruitment for this sub-study stemmed from the parent study. Methods for recruitment included: dear doctor letters, flyers, and postings on San Mateo Medical Center and Center Watch clinical trials websites. A series of focus groups were organized to get community input regarding the study. Changes were made to the study as a result of the focus groups with the intent of improving recruitment, but no such improvement occurred. In total, only three patients were recruited into the sub-study, and thus did not provide enough data for analyzable results.
Anecdotal evidence suggests that marijuana has potential benefits for AIDS wasting syndrome, nausea associated with chemotherapy, and a variety of other conditions. Conditions which are not effectively addressed by standard methods of treatment have the highest priority for study, and reports such as NIH's Workshop on the Medical Utility of Marijuana indicate that "neuropathic pain represents a treatment problem for which currently available analgesics are, at best, marginally effective. Since delta-9-THC is not acting by the same mechanism as either opioids of NSAIDs, it may be useful in this inadequately treated type of pain". To lay groundwork for studying MMJ's utility for this condition, the study will use, as subjects, individuals with HIV who are suffering from distal symmetric poly neuropathy (DSPN).
Given the need to establish feasibility and safety of self-administered smoked MMJ, the study does not expect to draw any definitive conclusions about the activity of MMJ vis-à-vis neuropathy. The study utilizes a relatively small sample and a limited study period in order to minimize the chances of any adverse consequences for subjects. However, the study will obtain pilot data on MMJ and neuropathy, which could lay the groundwork for studies with a larger sample conducted over a longer period, and these future studies would provide more definitive data.