Federal Marijuana Prohibition No Hurdle to New Study

The US Food and Drug Administration considers medical marijuana use an untested alternative therapy. But with marijuana sales now legal in Colorado, a Denver research team led by Edward Maa, MD is recruiting patients for a scientific study involving the plant. Maa and colleagues will conduct an observational study to evaluate a marijuana compound's efficacy in treating Dravet Syndrome.

The US Food and Drug Administration considers medical marijuana use an untested alternative therapy. But with marijuana sales now legal in Colorado, a Denver research team led by Edward Maa, MD is recruiting patients for a scientific study involving the plant.

Maa and colleagues will conduct an observational study to evaluate a marijuana compound’s efficacy in treating Dravet Syndrome.

The disease is a genetically based form of epilepsy called Dravet Syndrome.

Despite the fact that marijuana use is still illegal under federal law, the study design was reviewed and approved by the U.S. Institutional Review Board and listed on the US National Institutes of Health website detailing clinical trials.

One requirement of the trial is that participants have to be “self-seeking” marijuana treatment for their seizures.

Maa , a neurologist specializing in epilepsy at the University of Colorado School of Medicine in Denver and Denver Health Medical Center, and his team will try to determine whetherDravet patients respond to treatment with a type of marijuana called Charlotte’s Web. It is also sold as “R4.”

The plant is named after a six-year-old child whose debilitating epilepsy seizures have apparently lessened dramatically after regulartreatment with oil extracted from the marijuana strain.

Marijuana growers have said the strain is low in tetrahydrocannabinol, a psychoactive compound. But it is high in cannabidiol, which appears to mute the electrical activity in the brain that causes seizures.

So far the evidence is all anecdotal. Maa wants to change that.

According to a description of the planned research on the US National Institutes of Health website the study will be open only to patients who test positive for a mutation on the SCN1A gene.

That mutation is associated with Dravet syndrome.

Not all patients with the disease appear to respond to cannabidiol therapy and one goal of the study is to see if there are genetic differences that might show which patients would benefit, if any.

Patients who complete three months of therapy with at least a 50% reduction in the frequency of seizures will be considered to have responded to the treatment.

Enrollment is open to Dravet patients ages one to 50 who have uncontrolled epilepsy and are seeking to try Charlotte’s Web with the assistance of a physician. The endpoint for data collection is in Feb. 2016.

The investigation is funded by the University of Colorado and Denver Health Medical Center.