The main limitation refers to the BOI study and clinical trials used to populate the model inputs. Any limitations regarding inputs from these sources directly apply to this economic evaluation as well. Although the model used data from two clinical trials and a long-term follow up study, the total number of patients may not be sufficient to fully reflect the real-world sample.
- Dr. Herzberg is co-founder and Clinical Director of Sage Integrative Health, a holistic health and ketamine clinic in Berkeley, CA that offers psychedelic-assisted therapies as they become legal from a holistic, trauma-informed, and relational perspective.
- This indicates that much remains unknown about the safety profile of MDMA-AP.
- Clinical trial data supporting the study findings were used under license from Lykos Therapeutics and are publicly unavailable.
- Participants were excluded if they could not safely taper off psychiatric medications, which was required for study participation.
The Mitchell Study
If people with PTSD want to learn about participating in current clinical trials for MDMA therapy, they can talk with a healthcare professional. This is the final stage before potential approval from the FDA, which would make it available as a treatment option in the United States. A 2020 pilot study of 18 participants investigated MDMA therapy as a treatment for anxiety in people with a life threatening illness.
MAPS PBC Publishes Results of Successful Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD
Although low-dose MDMA improved blinding in phase 2 studies, it led to decreased effectiveness compared with an inactive placebo in a PTSD population, making it easier to detect a difference between the active and comparator groups15. The how long does mdma stay in body use of inactive placebo also allows for uncontaminated comparison of safety data between groups. Therefore, an inactive placebo was determined in partnership with the FDA as a more conservative statistical comparison, and the study utilized observer-blinded efficacy assessments to minimize bias in efficacy measurements. Attentive but usually silent, supporting the emerging process, and offering assistance and guidance if needed. In addition to listening and responding to the patient when they speak, the therapists offer little analysis of the material but may ask questions for the patient to reflect on what is coming up for them. During her research, she learned about psychedelic-assisted therapy, an emerging treatment seeing growing interest from Canadians with end-of-life anxiety, treatment-resistant depression and other mental health conditions.
Will the FDA Approve Psychedelic MDMA To Treat PTSD? What to Know
An association with MDMA was determined based on the relative incidence of TEAEs with at least a twofold difference between the MDMA and placebo groups. A hierarchical testing strategy was used to control for type I error, such that the hypothesis for the key secondary endpoint (SDS) would be tested only if the statistical test for the primary efficacy comparison rejected the null hypothesis. The primary outcome analysis was replicated independently by one blinded programmer and one unblinded programmer. Genesee Herzberg, PsyD received her doctorate in Clinical Psychology from the California Institute of Integral Studies, where she wrote her dissertation on the phenomenology and sequelae of MDMA-assisted therapy. She trained in MDMA-assisted therapy for PTSD with the Multidisciplinary Association for Psychedelic Studies (MAPS) and in ketamine-assisted therapy with the KRIYA Institute.
PTSD affects millions of people worldwide
One-third of participants identified their race as “other than white,” and over one-fourth identified their ethnicity as Hispanic/Latino. “So this development is very exciting, and hopefully will lead to a significant new treatment option for people who really need it,” he told Healthline. 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.
What Is MDMA-Assisted Therapy for PTSD?
- Across all studies, there was no difference in the odds of withdrawing from the study for any reason in the MDMA-AP group compared with controls, and all specific reasons for withdrawal were also non-significant (Table S3).
- The average QALY increment was 0.376 (±0.305 standard deviation) with mean utilities of 3.691 in the MDMA-AT arm and 3.315 in the placebo with therapy arm.
- Of the psychedelic substances currently being studied for therapeutic uses, MDMA shows strong evidence for treating mental health conditions, including post-traumatic stress disorder (PTSD).
- COne participant in the placebo with therapy group completed the study but had missing item-level data on the final CAPS-5 assessment, and the final assessment was not included in the analysis of the de jure estimand.
- During these conversations, the participant has the opportunity to process, make sense of, give meaningful expression to their psychedelic experience, and receive therapeutic support for any challenging issues that may come up during the MDMA session.
- After completing the phase III trials, some participants were included in the long-term follow-up study (MPLONG) which was used to estimate the durability of treatment effects.
The study sample was mostly female and White/Caucasian, although males and persons of other ethnicities were also represented. After all participants received three MDMA sessions, results indicated significant improvements in outcomes at treatment exit, 6-month and 12-month endpoints. However, the interpretation of these results was limited due to lack of a control group after crossover. Early investigations with psychedelic compounds such as lysergic acid diethylamide (LSD) suggested that psychoactive substances held promise in addressing distress, pain, and anxiety in people with LTIs6,7. Randomized, placebo-controlled trials reported reduction in symptoms of anxiety and depression compared with controls, with some indication that symptom reduction might be linked to subjective drug effects, such as strength of a mystical experience15.
