The safety and efficacy of MDMA-assisted therapy is currently under investigation. It is not yet approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings.
PTSD affects millions of people worldwide
12M adults in the U.S. suffer from PTSD during a given year
350M+ people suffer from PTSD worldwide
Sources: U.S. Department of Veterans Affairs, National Center for PTSD Global Prevalence: https://www.uptodate.com/contents/posttraumatic-stress-disorder-in-adults-epidemiology-pathophysiology-clinical-manifestations-course-assessment-and-diagnosis PTSD War Population: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394282/pdf/zept-10-1578637.pdf
Why MDMA?
MDMA is capable of inducing unique psychopharmacological effects, such as:
Decreased feelings of fear and defensiveness
Increased feelings of wellbeing
Increased sociability and extroversion
Increased interpersonal trust
An alert state of consciousness
MAPS recently completed MAPP2, the second of two Phase 3 trials to support FDA approval of this Breakthrough-Designated therapy. With this completion, MDMA-assisted therapy is expected to receive FDA evaluation in 2023.
In our first Phase 3 study, 88% of participants with severe PTSD experienced a clinically significant reduction in PTSD diagnostic scores two months after their third session of MDMA-assisted therapy, compared to 60% of placebo participants.
Additionally, 67% of participants in the MDMA group compared to 32% of participants in the placebo group no longer met the criteria for PTSD two months after the sessions.
MDMA-assisted therapy is delivered during three 8-hour sessions, scheduled three to five weeks apart, along with 12 non-drug therapy sessions to aid with preparation and integration.
MDMA is a triple reuptake inhibitor that produces anxiolytic and prosocial effects through the release of neurotransmitters such as serotonin, norepinephrine, and dopamine.
MDMA also increases the release of oxytocin and prolactin (hormones associated with trust and bonding) as well as hormones that influence the HPA axis and stress response.
MDMA decreases activity in the left amygdala (associated with fear and trauma) which may allow patients to more openly discuss their memories in therapy.
The world’s most advanced psychedelic-assisted therapy trial has confirmed positive findings in the second Phase 3 trial of MDMA-assisted therapy for PTSD.
FOR IMMEDIATE RELEASE: November 17, 2022 MAPS Public Benefit Corporation (MAPS PBC) has announced that the final participant in the second Phase 3 trial of psychedelic-assisted therapy, A Multi-Site Phase …
Two new study sites are now enrolling for our MDMA-assisted therapy for PTSD Expanded Access program. The Pearl Institute in Waynesville, North Carolina, and Sage Integrative Health in Berkeley, California, …
Our Expanded Access Program study site at Sage Integrative Health in Berkeley, California, began screening participants for MDMA-assisted therapy for PTSD in early March. Our multi-site expanded access …
We encourage you to read and follow maps.org/safety for detailed information regardingMAPS Code of Ethics for Psychedelic Psychotherapyand our practices to create a culture of safety in psychedelic therapy. …
Our multi-site expanded access study site for MDMA-assisted therapy for patients with treatment-resistant PTSD at the Pearl Psychedelic Institute in Waynesville, North Carolina, was activated for phone …
On December 10, 2021, our multi-site expanded access study site for MDMA-assisted therapy for patients with treatment-resistant PTSD at the Pearl Psychedelic Institute in Waynesville, North Carolina, was …
Revenue share payments will be based on North America sales of MDMA for use in MDMA-assisted therapy, will terminate after 8 years, and include a reciprocity payment structure that reduces payments once …
Fifty years after the War on Drugs was officially declared and psychedelic substance prohibition began in contravention of evidence supporting therapeutic use, the California State Senate has taken the …
We’ve finally reached the point where we can shout our good news from the roof tops and publicly celebrate the work of this amazing team! The publication of our MAPP1 findings is official as of this …
A Phase 1/2 open-label treatment development study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in dyads in which one member has chronic posttraumatic stress disorder (PTSD) shows MDMA-Assisted …
On the heels of United Nations’ Commission on Narcotic Drugs removal of medical marijuana from the list of most dangerous drugs, lawsuit demands processing and approval of licenses to support research …
