The studies approved by the DEA are:
- "Short-Term Effects of Cannabis Therapy on Spasticity in Multiple Sclerosis" Project Director Jody Corey-Bloom, M.D. (UCSD) - An outpatient study of the efficacy and safety of smoked marijuana versus placebo for the treatment of muscle spasms, loss of function, and related pain in patients with Multiple Sclerosis (M.S.).
- "Placebo-controlled, Double-Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy" Project Director Ronald Ellis, M.D., Ph.D., (UCSD) - An outpatient study on the efficacy of smoked marijuana versus placebo for the alleviation of peripheral nerve pain associated with HIV infection.
DEA Administrator Asa Hutchinson said "this announcement is consistent with the DEA position that the question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine".
Igor Grant, M.D., director of the CMCR at the University of California, San Diego (UCSD) stated that "the approval of these clinical trials by the DEA and other federal and state agencies provides a unique opportunity to conduct much needed rigorous scientific studies that can determine if cannabis products have a role in ameliorating suffering or improving prognosis in severe medical conditions for patients that might not have benefited fully from other treatments."
In addition to exploring possible benefits, these studies will monitor potential side effects and toxicities. In particular, the following sub-study will investigate effects on complex behaviors such as driving skills.
- "Impact of Repeated Cannabis Treatments on Driving Abilities", Project Director Thomas Marcotte, Ph.D., (UCSD) - An outpatient study on the effects of repeated administration of medicinal cannabis on driving ability (acute and/or long-term). Patients with HIV-related neuropathy or spasticity associated with M.S. will be evaluated for impairments using driving simulator assessments.
A further study at University of California, San Francisco (UCSF) is pending DEA approval, anticipated in the near future.
- "Cannabis for the Treatment of HIV-Related Peripheral Neuropathy", Project Director Donald Abrams, M.D. (UCSF) - An inpatient study on the efficacy of smoked marijuana for the alleviation of peripheral nerve pain associated with HIV infection.
The CMCR, headquartered at UCSD and UCSF, is a statewide, state-funded initiative to study the safety and efficacy of medicinal cannabis to treat certain medical conditions. The Center supports and coordinates scientific research at universities and research centers throughout California, assessing the use of cannabis as an alternative for treating specific medical conditions. Diseases and conditions targeted for treatment are those that have been identified as warranting further research by the National Academy of Sciences, Institute of Medicine, and by a National Institutes of Health expert panel.
Before studies are submitted to the state and federal regulatory review agencies, an external Scientific Review Board, composed of national senior scientists, conducts a thorough review of each study, only approving studies of the highest scientific standards. The CMCR also has a National Advisory Council in place to advise and assist the Center’s directorate.
After approval by the Scientific Review Board, each of the above studies were approved by the Research Advisory Panel of California, the Department of Health and Human Services (DHHS), the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA). The studies will order product from NIDA and are expected to begin recruitment at the beginning of next year.