Drug Enforcement Administration (DEA) officials recently gave final approval for three state-sponsored patient trials on the therapeutic potential of smoked marijuana. The decision reverses a nearly two decade federal de facto prohibition on medical marijuana research.
All three patient trials will take place at University of California’s Center for Medicinal Cannabis Research (CMCR), headquartered at the Universities of California at San Diego (UCSD) and San Francisco (UCSF). One study will examine the safety and efficacy of smoked marijuana versus placebo for the alleviation of peripheral nerve pain associated with HIV infection. Another will examine the efficacy of inhaled marijuana versus placebo for the treatment of muscle spasticity in Multiple Sclerosis patients. A sub-study of the latter cohort will also examine the impact of marijuana on psychomotor skills using driving simulator assessments. Each study will use federally approved pot from the National Institute on Drug Abuse (NIDA). Patient recruitment for the trials is expected to begin early next year. Patients interested in participating in the studies should visit the CMCR website at: http://www.cmcr.ucsd.edu/partinfo/index.htm for more information.
The CMCR, established in August 2000 and funded by the state of California, supports and coordinates research assessing the use of cannabis as a medicine. Last February, the Center’s independent Scientific Review Board approved four medi-pot clinical trials. After more than nine months of review, federal regulatory agencies and the DEA have finally signed off on three of the trials. The fourth – a proposed inpatient study on the effectiveness of smoked marijuana on HIV-related neuropathy by noted UCSF AIDS researcher Dr. Donald Abrams – still awaits final approval from the DEA, though a CMCR spokeswoman said that they expect authorization for that study within a matter of weeks. Abrams has been attempting to gain federal permission to conduct such a study for more than five years. A previous study by Abrams found that smoked marijuana does not disrupt the effectiveness of anti-retroviral drugs in HIV patients. Subjects who smoked marijuana in the study were also found to have gained significantly more weight on average than those receiving placebo, and had slightly lower viral levels.
Presently, seven additional FDA and NIDA-approved medical marijuana studies – including three on cannabis and analgesia – are also awaiting approval from the DEA. It remains uncertain if and when the DEA will approve the research, without which none of the clinical trials may move forward. Of the recently approved protocols, all three received FDA and NIDA authorization to proceed several months before the DEA finally endorsed them.
“While it is encouraging to see that the federal government is finally taking the necessary steps to allow legitimate research into the medical utility of marijuana, it is disturbing to think that one agency – the DEA – may be needlessly delaying this research because they fear the results may undermine their flat Earth-like position that marijuana has no medical value,” said Paul Armentano, director of publications and research for the NORML Foundation. “By waiting until now to finally get serious about unlocking pot’s therapeutic potential, thousands of seriously ill patients have unnecessarily suffered at the hands of politicians.”
For more information, please contact either Paul Armentano or Allen St. Pierre of The NORML Foundation at (202) 483-8751. For more information on the CMCR’s clinical research trials, please visit: http://www.cmcr.ucsd.edu/geninfo/research.htm.
