Last week, after months of deliberation, the U.S. Food and Drug Administration officially rejected the use of MDMA, the synthetic stimulant and psychoactive drug, as treatment for PTSD. As a psychiatrist and trauma specialist who works with sexual assault survivors, I feel confident the FDA made the right decision for trauma survivors — especially those who’ve endured sexual violence.
MDMA-assisted therapy (MDMA-AT) for PTSD gave many hope for a new treatment option during a time when care is largely inaccessible. While 1 in 11 people in America will develop PTSD in their lifetime, 80% of them will never access treatment and are left to manage symptoms including flashbacks, intrusive thoughts, hypervigilance and negative mood on their own. Effective treatments exist, like Cognitive Processing Therapy and Prolonged Exposure, and the field is continuously making breakthroughs in new therapy approaches, medications, and yes — psychedelics.
But the MDMA-assisted therapy program presented to the FDA by Lykos Therapeutics has me worried, primarily because it can lead to intolerable risks for sexual violence and rape survivors. While many people believe PTSD is synonymous with veterans, it actually most commonly affects sexual-assault and domestic-violence survivors, who are often women and minoritized individuals.
My concern isn’t around the use of psychedelics themselves as much as how the treatment is facilitated. Startlingly, MDMA-AT is the only clinical protocol that encourages physical touch between patient and therapist, a behavior historically seen as unethical, unsafe and prohibited in the therapeutic relationship. The treatment manual for MDMA-assisted therapy, used by Lykos for its trials, includes an instruction guide on how therapists can and should touch patients physically, which includes hand-holding, hugging and “focused bodywork” while the patient is in a mind-altered state. The guide reiterates that withholding touch “may even be perceived by the participant as neglect.” Only one of the two providers present needs to be a licensed professional — meaning one can be a layperson trained by Lykos but with no clinical training, introducing further risk of misconduct. Additionally, the protocol requires an unusually long amount of time — MDMA-AT takes 42 hours with sessions that last up to 6-8 hours, while existing therapies see results within 10-15 total hours across one-hour sessions.
This practice of touch between therapist and patient strikes an uncomfortable resemblance to exploitative practices in the history of therapy, where women were victimized by (mostly male) therapists. This history is not so remote — a 1973 study reported that up to 13% of psychiatrists had “erotic contact” with a patient, a practice now derided and forbidden in the field.
The introduction of touch calls into question whether a patient can even consent in the therapist-patient power dynamic especially while intoxicated — and I worry that this therapy could retraumatize and endanger survivors who have already endured unthinkable sexual violence.
This has already come true for a survivor of sexual violence who participated in one of Lykos’s trials. As reported by New York magazine, two Canada-based therapists who were part of the study forcibly cuddled, spooned, blindfolded and physically restrained a visibly distressed patient throughout the MDMA treatment. The male therapist involved in this incident, who can be seen on video pushing his groin into the patient’s back, allegedly proceeded to sexually assault the patient repeatedly for a year.
After the patient reported the abuse, no disciplinary action was taken for three years, besides her being reimbursed $15,000 to seek further therapy.
There are further reports of misconduct and serious adverse events during the trials, with few substantial changes made to prevent future harm. Another patient reported being pressured to “cuddle” with her therapist. Three others reported that the treatment made them suicidal.
All of this gives me a profound sense of responsibility to protect these vulnerable survivors — and relief that, in its current form, MDMA-AT has not been approved. I see patients every day who can’t be touched by their own family due to the abuse they’ve endured; why would we subject them to physical touch by a health care provider when they are in a mind-altered state and cannot consent?
Where do we go from here? I believe that psychedelics may be a promising future treatment for PTSD, but they must first and foremost ensure the welfare of PTSD patients. Lykos will need to start from the beginning to ensure that its care model is truly trauma-informed; they will need to redesign their psychotherapy protocol and work to rebuild trust with survivors by improving the safety, privacy and reporting practices in their clinical trials. They may need to scrap their own proprietary therapy and study the use of MDMA when added to the protocol of existing psychotherapies that have already been found to be effective and safe.
The first rule of health care is “do no harm.” If MDMA-AT is ever going to be approved to treat PTSD, we must ensure that the protocol is trauma-sensitive and has been broadly vetted through the lens of patient safety. Sexual assault simply cannot be a potential risk of completing MDMA-assisted psychotherapy, especially for survivors who have already experienced this horror.
Dr. Sofia Noori (sofia@nemahealth.com) is a psychiatrist at Yale School of Medicine and founder and CEO of Nema Health.