Research of cannabidiol, a non-intoxicating component of the cannabis plant, has been made easier because of new regulations released this week by the Drug Enforcement Administration.
The federal agency has waived certain registration requirements for researchers conducting U.S. Food and Drug Administration-approved clinical trials. The ease in paperwork and bureaucratic processing for CBD research is designed to speed the development of FDA-approved CBD medications that can be used to treat epilepsy and seizure disorders.
Federal law requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration. This registration permits the possession of a specific amount of CBD for a specific research protocol. Before now, researchers who expanded the scope of their studies and needed more CBD than they were granted initially had to submit a written request for modification to their DEA research registration. The modification-approval process, which includes both the DEA and the FDA, potentially delayed research.
Under the new guidelines, a previously registered CBD clinical researcher who is granted a waiver can readily modify a research protocol and continue to work seamlessly. This waiver effectively removes a step from the approval process.
The changes are consistent with recommendations made by Smart Approaches to Marijuana (SAM), a nonprofit organization that champions responsible research and opposes the drug’s legalization. (Dr. Christian Thurstone, whose website you’re reading, serves on SAM’s science advisory board.)
“Given the potential benefit of CBD, waiving onerous research requirements is the right thing to do, and DEA should be commended,” said Kevin Sabet, a former White House drug policy advisor who serves now as president of SAM. “It shows we do not have to legalize marijuana – either in name or de facto via state ‘medical’ programs – to provide access to promising components of marijuana.”
Research of cannabidiol and other ingredients of the cannabis plant for the development of non-smoked, FDA-approved medications has happened for decades and has resulted in drugs such as Epidiolex, Sativex and Marinol. Drugs receiving FDA approval demonstrate efficacy, have exactly known contents, have documented side effects, can be replicated exactly and can be dosed precisely. Marijuana and the various forms of THC (the active ingredient that makes users high) sold in dispensaries and retail shops have not met those standards. Similarly, many CBD oils, such as the highly promoted Charlotte’s Web, have not met those standards. The marijuana shops’ products are marketed aggressively to the public by a rapidly growing industry that works to circumvent the requirements of federally approved research and the responsible practice of medicine. Also worth noting: marijuana smoked recreationally today contains almost no CBD.
“We commend DEA Administrator Chuck Rosenberg for this reform,” said Dr. Stuart Gitlow, immediate past president of the American Society of Addiction Medicine and SAM’s vice-chairman. “It’s time we do more research and, importantly, separate the medical use issue from the issue of legalizing the drug.”
Christine Tatum is a veteran journalist — and Dr. Thurstone’s wife. She is a contributing member to The (Colorado Springs) Gazette Editorial Board’s perspective series about marijuana’s impact on the state of Colorado, Clearing The Haze. She also joined Dr. T to write, Clearing The Haze: Helping Families Face Teen Addiction.
We welcome all thoughtful comments, but please abide by our commenting rules