BOULDER, COLORADO - Doctors across the U..S could soon be prescribing formerly illegal drugs as therapy for two hard-to-treat diseases - childhood epilepsy and Post-Traumatic Stress Disorder. A growing body of scientific evidence is leading the U.S. Food and Drug Administration to take a closer look at cannabidiol, an extract of marijuana, and MDMA, an ingredient in the party drug ecstasy.
The makers of a cannabidiol product named Epidiolex have now completed all three phases of FDA-approved clinical studies. The submission for FDA approval includes clinical data on 1,500 patients, 400 of whom had used it for more than a year. If it is approved, Epidiolex could be part of the legal arsenal for treating epilepsy within a year.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit organization focused on beneficial medical uses of psychedelics and marijuana. It funded six Phase 2 FDA-approved clinical studies of MDMA combined with therapy for treating Post-Traumatic Stress Disorder. The only PTSD medicines currently approved by the FDA usually don’t work well, says Boulder, Colorado, psychiatrist Will Vanderveer, “and leave millions of people still symptomatic and suffering. And dying from suicide."
Vanderveer worked with psychotherapist Marcela Ot’Alora, who led the study, which ran for more than three years. Each of the 28 participants was given a monthly dose of MDMA and weekly therapy sessions over the course of three to six months. When they were given MDMA, therapists stayed with them during the eight hours the drug was active, helping them process past traumas in a more effective way.
Ot’Alora says the MDMA promoted trust with the therapists, and the insights gained were profound.
“It could be crying, it could be even screaming. They realize, 'wow, I was completely going away and dissociated from the experience, and now I see what was really happening.' Anger can come up, really getting in touch with the anger at what was done to them.”
Karen, one of the participants, was plagued by nightmares and dread after being sexually abused as a child. She says that decades of therapy and anti-depressant drugs did not help, but this protocol did.
“I don't walk around just thinking I'm garbage anymore. You know, I feel like, wow, you know, I'm kind of a good person here.” James was a combat medic, and returned from a tour of duty in Afghanistan with PTSD. He tried a number of different therapies, but still felt like he was in a dark cave, with no way out. Then he found the MDMA study. In an on-line documentary about the study, he describes the drug as "a kind of light," and the therapists as "guides. And I could see around the cave and figure out how to get out of there. It was really helpful."
The MDMA plus therapy protocol eliminated symptoms in nearly 70 percent of the participants previously diagnosed with treatment resistant PTSD. The final step before requesting FDA approval as a prescription medicine is Phase Three trials, which are scheduled to begin next year.