- Pilot study explored the application of MDMA-assisted psychotherapy in 18 individuals experiencing moderate to severe anxiety following diagnosis with a life-threatening illness
- The primary outcome, change in State-Trait Anxiety Inventory (STAI) Trait Scores, indicated a greater reduction anxiety among the group receiving MDMA (− 23.5) compared to the placebo group (− 8.8) with a large effect size
- Future clinical trials with larger sample sizes and more diverse populations are warranted to study the application of MDMA-assisted psychotherapy for treating anxiety in this population
Santa Cruz, CA, November 24, 2020 – A peer-reviewed study published today in the journal Scientific Reports provides sufficient evidence to support further research into the palliative effects of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. The pilot study, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and using protocols developed by MAPS Public Benefit Corporation (MAPS PBC), demonstrated greater reduction in anxiety among participants who received MDMA relative to participants who received placebo with identical psychotherapy. While the difference between the two groups was not statistically significant, this small pilot study demonstrates the addition of MDMA to the intervention had a large effect size and justifies continued research.
Individuals facing a life-threatening illness may contend with anxiety, depression, anger, and despair that often exacerbate the distress already caused by the illness itself. The trauma of a devastating illness is often deep and difficult to integrate, even for those who recover. As modern medical care improves life expectancy or recovery rates for serious illnesses, the need to address the psychological trauma of diagnosis and treatment is growing.
Phil Wolfson, M.D., served as Principal Investigator and lead author for the study and authored an accompanying commentary. “Through this intensive psychotherapy, with MDMA experiences as a fundamental part of the process, people who have trauma from life-threatening illnesses were able to significantly improve the impact of their traumatic residues, their fears of relapse and death, and their struggle to make recoveries. The traumatic nature of diagnosis with a life-threatening illness and its aftermath contains a multiplicity of manifestations in cognition, motivation, affect, spirit, meaning, relationships, and view of self. Attention to patients’ suffering, impacted ways of being, and tension with potential recurrence of illness and death should be considered as fundamental to their complete recovery or hospice care as attention to their physical state; this pilot study validates continued research into MDMA-assisted psychotherapy as a meaningful pathway to addressing their suffering.”
Early investigations with psychedelic compounds suggested such psychoactive substances hold promise in addressing distress, pain, and anxiety in people with life-threatening illnesses. Recent studies provide evidence for the use of psychedelic-assisted psychotherapy as an efficacious modality for the treatment of depression, anxiety, and PTSD. MDMA is under investigation as an adjunct to psychotherapy for various anxiety-related conditions; results from six Phase 2 studies lead the U.S. Food and Drug Administration (FDA) to issue a Breakthrough Therapy designation for MDMA-assisted psychotherapy for treatment of PTSD in 2017. Based on these findings, this pilot study was conducted to examine the safety and efficacy of MDMA-assisted psychotherapy to alleviate anxiety and other psychiatric symptoms, including depression and poor sleep quality, related to a life-threatening illness.
“This study presents a new viable pipeline for the clinical application of MDMA-assisted therapy in the treatment of anxiety symptoms in a population in dire need of palliative care options,” noted Berra Yazar-Klosinski, Ph.D., who serves as Deputy Director and Head of Research Development and Regulatory Affairs for MAPS PBC. “Patients suffering from a life-threatening illness are often only treated for their primary medical diagnosis; their anxiety and existential distress is neglected in our current healthcare system. MAPS has a strong record of supporting treatments addressing this unmet medical need. The results of this pilot study will enable the design of future well-powered studies to change this treatment landscape, and perhaps even the way we approach life and death in our modern lives.”
A total of 18 participants with moderate or severe anxiety symptoms related to diagnosis of a life-threatening illness were enrolled in the study; 17 completed the treatment and follow-up assessments after six and twelve months. Participants had a mean age of 54.9 years; fourteen participants identified as female; and many had been previously diagnosed with an anxiety disorder (83.3%), major depression (77.8%), PTSD (72.2%), or insomnia (61.1%). Notably, after the experimental sessions, participants who initially received a placebo with therapy received additional therapy sessions with MDMA and results for both groups were combined for the six- and twelve-month follow-up assessments. Study limitations included small sample size, demographic homogeny, exceptionally strong positive response from one member of the placebo group, and combination of the experimental and control groups following the experimental sessions. Study results support the feasibility of exploring MDMA-assisted psychotherapy as a novel approach for potential long-term treatment of anxiety related to life-threatening illness and will inform development of future clinical trials with larger sample size and among more diverse populations.
Interviews with study authors are available via maps.org/mediarequest
The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation. It has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.
Betty Aldworth, Interim Communications Director
maps.org/mediarequest or [email protected]
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. More information about the organization is available at mapspublicbenefit.com.