Final phase trials for MDMA-assisted psychotherapy to treat PTSD
After decades of research and advocacy, the Multidisciplinary Association for Psychedelic Studies (MAPS), led by Rick Doblin, has moved into the final stages of its work pushing for MDMA-assisted psychotherapy treatment of post-traumatic stress disorder (PTSD). MAPS and the FDA have agreed on the design of the Phase III trials and, if successful, the drug could be available as a legally prescribed treatment for PTSD sufferers as soon as 2021.
First synthesized in 1912, 3,4-Methylenedioxymethamphetamine (MDMA) was rediscovered in the mid-1970s by pioneering psychopharmacologist Alexander Shulgin. Informal self-trials by Shulgin and his colleagues identified the drug as compellingly psychoactive and possibly useful for psychotherapy.
Learning from the criminalization narrative of LSD, the drug was informally spread around small networks of doctors, psychiatrists and psychiatrists for several years, with many trying to avoid the compound moving into large-scale recreation circles. By the late 1970s and early 1980s, several therapists were using the drug unofficially in treatment, discovering it to have starkly positive effects on patients.
Of course, use of the drug couldn't be contained and it rapidly spread into recreational and party environments. By 1985 the DEA caught up and successfully had the drug classified as Schedule I, despite many protests touting its medical benefits. The stigma of MDMA's illegal status, and its movement through the following era's "rave" scene, effectively froze the ability for scientists to continue working with the drug in clinical conditions.
MAPS was founded in 1986, the very year after MDMA was scheduled, and while its overall purview was to work in promoting clinical research into medical uses for psychedelic substances, one of the primary targets of the organization was the legitimization of MDMA for psychotherapy. Initial studies displayed extraordinary success in MDMA helping patients overcome PTSD when used in conjunction with psychotherapy.
After several Phase II studies were conducted around the world, it was found that 68 percent of subjects were considered free of PTSD symptoms up to twelve months after a twelve-week treatment. All Phase II subjects were selected for having chronic, treatment-resitant PTSD and suffered from the condition for an average of over 17 years.
The structure of the Phase III trial is set to mirror most of the early studies. Over a twelve-week treatment period, patients will undergo three, day-long MDMA-assisted psychotherapy sessions, alongside twelve preparatory and integration therapy sessions. Participants will be randomized against a control group, who will undergo the same process but receive a placebo.
In addition to this final phase approval, the FDA has granted these trials a Breakthrough Therapy Designation. This FDA qualification is given to drugs that preliminary trials have demonstrated offer substantial improvements over current treatments and allows the approval process to be expedited in a more timely and efficient way than usual.
All things going well, MAPS estimates the MDMA-assisted, PTSD treatment could become an approved prescription medicine by 2021. As well as offering a revolution in treatment for those suffering from PTSD, this would mark a breakthrough in the legitimization of psychedelic medicines. A variety of scheduled drugs stigmatized through recreational uses are currently being examined for their medical potential, and this achievement by MAPS will hopefully remove the taboo that has frozen so much clinical research for so many years.