Lawmakers in numerous states, including Alabama, Mississippi, Kentucky and Wisconsin, hailed the passage of legislative measures this past spring calling for state-sponsored clinical trials to assess cannabidiol-rich oil in children with intractable epilepsy. In truth, however, such trials are likely years away from taking place, if they ever occur at all.
 
Because federal regulators classify cannabidol (CBD) as a schedule I prohibited substance, multiple federal agencies -- including the FDA, DEA, NIDA (US National Institute of Drug Abuse) and PHS (Public Health Service) -- must all sign off on any clinical investigation of the non-psychotropic cannabinoid, including state-sponsored research studies. But this approval process is typically an expensive and arduous one. 
 
For example, researchers at the University of Arizona in 2011 submitted an FDA-approved protocol to PHS to evaluate smoked cannabis in veterans suffering from post-traumatic stress. Public Health Service officials spent nearly three years deliberating over the merits of the study before ultimately approving a revised protocol in March of 2014. Nonetheless, the trial is still not yet underway because NIDA presently possesses an insufficient supply of the CBD-dominant cannabis strains necessary for the study. (Earlier this month, officials from the DEA acknowledged that the agency is increasing its marijuana production quota from 21 kilograms to 650 kilograms, about 1,443 pounds, in order to meet increasing clinical demand for the plant.) 
 
It is likely that these newly proposed, state-sponsored protocols will be met with similar bureaucratic delays. By contrast, safety trials involving the high-CBD pharmaceuticalized extract Epidiolex -- which was recently granted Orphan Drug Status by the FDA -- are already ongoing.
 
In a story published this week in USA Today, researchers from the University of Kentucky at Louisville acknowledged publicly for the first time that the preliminary cost of conducting such studies could be as much as $10,000 per participant and that the process of designing and approving the trials “could likely take months, if not years.” That’s a far different story than the one spun by Kentucky lawmakers this past spring when both chambers unanimously passed the CBD-research bill (and, in the process, elected to kill an alternative proposal seeking to outright legalize the possession and distribution of whole-plant cannabis).
 
“This was one of those tingly moments you get when you pass a bill that you really know is good for the commonwealth,” said Republican Julie Denton, the bill’s Senate sponsor, in March. “It is really going to help people’s lives.”
 
Someday perhaps it will. But for now, not so much.