Posttraumatic stress disorder (PTSD) is a chronic and devastating illness associated with high rates of disability and suicide. PTSD can be caused by war, sexual assault, childhood abuse, torture, violent crime, accidents, natural disasters, or other severely stressful events.
People living with PTSD often struggle to maintain healthy relationships and stay employed. PTSD patients often avoid expressing their emotions, suffer from persistent fear and hyper-arousal, and repeatedly re-experience their painful memories.
PTSD sufferers are unable to escape from their traumatic pasts. MDMA-assisted psychotherapy may show them a way out.
MDMA-assisted psychotherapy is an innovative treatment that combines psychotherapy with the administration of MDMA, a pharmacological adjunct.
In a recently completed pilot study, MDMA-assisted psychotherapy was shown to reduce PTSD symptoms below the diagnostic cutoff for 3.5 years or more.
MDMA (3,4-methylenedioxymethamphetamine) is a synthetic compound widely recognized for its ability to decrease fear and defensiveness while increasing trust and empathy. It may open a “window of tolerance” in patients undergoing psychotherapy for PTSD—and hold it open long enough for them to step through. 19
MDMA makes it easier for patients to be comfortable between the extremes of fear and avoidance, and may increase the effectiveness of psychotherapy by strengthening the alliance between therapist and patient.
MDMA promotes the release of oxytocin and prolactin, hormones associated with trust and bonding, 20 helping patients discuss their painful memories openly and honestly.
A full 83% of the subjects receiving MDMA-assisted psychotherapy in a flagship US Phase 2 pilot study no longer met the criteria for PTSD, and every patient who received a placebo and then went on to receive MDMA-assisted psychotherapy experienced significant and lasting improvements.
These results were published in July 2010 in the Journal of Psychopharmacology.
A long-term follow-up of patients who received MDMA-assisted psychotherapy revealed that overall benefits were maintained for an average of 3½ years or more.
We estimate that it will take $870,000 to be ready for our End-of-Phase 2 meeting with the FDA, and an additional $22.1 million and five years to complete Phase 3 and establish MDMA-assisted psychotherapy as a legally available treatment.
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