PTSD is a serious, debilitating disorder that negatively impacts a person’s daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilization, increased depression, and suicide risk.
People who suffer from PTSD may relive the traumatic experience through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. Symptoms can be severe and long-lasting. MDMA is a monoamine releaser and reuptake inhibitor with indirect effects on neurohormone release. The combined neurobiological effects reduce defenses and fear of emotional injury, enhance communication and introspection, and can increase empathy and compassion. MDMA may enhance fear extinction learning in humans. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic Process.
EntheoBliss Healthcare Foundation (EntheoBliss) is a small nonprofit organization working as a clinical trial sponsor to obtain approval for the prescription use of 3,4 methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD).
In this study, Entheobliss is cooperating with Multidisciplinary Association for Psychedelic Studies (MAPS), a tax-exempt charity providing knowledge, training, and substance for the clinical development program. The MAPS Data from a series of Phase 2 and phase 3 studies of MDMA-assisted psychotherapy sponsored by MAPS provide preliminary evidence that PTSD, independent of cause, is treatable with two to three sessions of MDMA-assisted psychotherapy and associated non-drug preparatory and integrative psychotherapy.
This confirmatory study will validate findings from previous MAPS investigations in terms of safety and effectiveness of manualized MDMA-assisted psychotherapy for PTSD. This study will also look at long-term effects (6 months, 12 months) of manualized MDMA-assisted psychotherapy for PTSD.
This study will also provide cross-cultural validation data on the updated version of the Primary Outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
In addition, the study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy while providing an opportunity for further investigations.
This Open-Label, Confirmatory Study of Manualized MDMA-Assisted Psychotherapy assesses the safety and effectiveness of MDMA- assisted psychotherapy in participants diagnosed with PTSD.
All safety data will be shared in the global safety database for MDMA maintained by MAPS.
Study participants will undergo three preparatory and nine psychotherapy sessions and three Experimental Sessions;
Fixed-dose of MDMA + adjunct manualized psychotherapy, preceded by a preparatory and medication tapering period. Then Baseline and Post-therapeutic assessments for both interventions will be compared.
The participants will be followed-up three times after each Experimental Session involving MDMA for data collection and safety purposes. The Primary Outcome measure, the Clinician-Administered PTSD Scale (CAPS-5) is assessed by a blinded Independent Rater (IR) multiple times throughout the study. The IR will be blinded to the number of treatments received and will not have access to data collected by the site during the active treatment period.