The UW School of Medicine and Public Health is participating in an upcoming trial to treat PTSD with a component of the drug nicknamed ecstasy.
The phase III trial is exploring the use of MDMA in combination with psychotherapy to treat post-traumatic stress disorder.
MDMA, otherwise known as “Molly,” is a component of ecstasy, a Schedule I drug. The Food and Drug Administration approved the therapeutic use of MDMA in August 2017, after a phase II trial came up with promising results.
After two sessions of MDMA-assisted psychotherapy, 56 percent of participants no longer met criteria for a clinic PTSD diagnosis. A year later, 68 percent no longer had treatment-resistant PTSD.
To follow up on those results, further research is being performed at 16 research sites in the United States, Canada and Israel. One of those sites will be in Madison, where at least seven of the 300 total study participants will be located.
The trial will be randomized and placebo-controlled. The Madison effort will be led by Dr. Randy Brown, an associate professor of family medicine, and Dr. Christopher Nicholas, an assistant professor, clinical psychologist and the co-principal investigator.
Trial participants will have three psychotherapy sessions, spaced three to five weeks apart. Some will get MDMA along with their therapy, and others will only get a placebo.
Both before and after the MDMA session, participants will discuss their feelings and any difficulties, as well as any new insights they may have gained.
“The participants are heavily screened and evaluated prior to enrollment,” Nicholas said. “After intense preparation of the participants, the drug is administered in a safe and secure clinical setting over an eight-hour period with two licensed clinical psychologists present and an on-call physician.”
PTSD is often characterized and diagnosed by hyperarousal, meaning those with the disorder will react more strongly to external stimuli. Nicholas says MDMA calms that down while increasing the participant’s feeling of comfort and connection with the therapist. This has been shown to make users more open to certain experiences, such as confronting the trauma that may have led to the PTSD.
According to a release from the UW School of Medicine and Public Health, clinical trials at all 16 sites are getting funding from the nonprofit Multidisciplinary Association for Psychedelic Studies.
–By Alex Moe