|FDA Approves Marijuana Study On Migraines|
Posted by FoM on October 09, 1999 at 09:22:14 PT|
NORML's Weekly Update News
Oct. 7, 1999, Missoula, MT: The Food and Drug Administration has granted approval to Ethan Russo, MD, a Montana neurologist, to study the effects of smoked marijuana as compared to oral dronabinol (Marinol(R)) and injected sumatriptan (Imitrex(R)) in the treatment of migraine headaches.
Russo will enroll 40 patients with severe migraines, and employ a double-blind, double-dummy crossover design (neither the patients nor examiners will know whether they are employing real cannabis or THC-free cannabis or true dronabinol or a placebo).
The study still faces a roadblock in the National Institute on Drug Abuse (NIDA). NIDA, the only American supplier of research marijuana, has recently changed its policy and will only provide marijuana to researchers whose studies have gained FDA approval as well as a NIDA Public Health Service review.
"NIDA has added a new hoop through which cannabis researchers must jump," Russo said. "For any other substance, even cocaine or heroin, approval of an Investigative New Drug (IND) application by FDA allows the researcher to proceed directly to clinical trials. NIDA has thrown up a new and unnecessary barrier to this research."
If NIDA demands changes in the protocol, Russo would need to file another IND application with the FDA which would cause further delays. In the meantime, the delay hinders Russo's ability to raise funding from private sources for the projected $250,000 study.
"Ethan's chances of obtaining approval for his marijuana/migraine study from NIDA's Public Health Service review are very good, simply because NIDA needs to show that it isn't blocking research," said Rick Doblin, President of Multidisciplanary Association for Psychedelic Studies (MAPS).
"For me the most intriguing question is not whether the protocol will be approved but what will NIDA charge for one pound of its low potency pot, which is all that Ethan needs for his study."
For more information, please contact:
Ethan Russo, MD
NORML's News Bulletin:
FDA-Approved Marijuana Study At Last Hurdle
National Institute on Drug Abuse
Marijuana & The Migraine - Research