Psilocybin and MDMA for Post-traumatic Stress Disorder (PTSD)
Johns Hopkins University
Summary
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet
Description
The proposed randomized, double-blind, active control study will compare a single experimental dose of co-administered MDMA + psilocybin (exact dosages not disclosed) with a single comparator dose of co-administered MDMA + psilocybin (exact dosages not disclosed). For the co-administered dosing session, MDMA will be given initially, followed by psilocybin 30 minutes later. Approximately 1.5 months after the first dosing session, a second single-blind (participant masked) dosing session will occur. The study will recruit adult Veterans with PTSD for ≥ 6 months.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * \>=21 years old * Military Veteran * Have given written informed consent * Able to swallow pills * Have a confirmed DSM-5 diagnosis of Post-traumatic Stress Disorder with symptom duration \>= 6 months * Have a baseline CAPS-5 score of \>=28 * Be judged by study team clinicians to be at low acute risk for suicidality * Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study. * Be medically stable as determined by screening for…
Interventions
- DrugPsilocybin
Experimental Psilocybin (exact dosages not disclosed)
- DrugPsilocybin
Comparator Psilocybin (exact dosages not disclosed)
- DrugMDMA
Experimental MDMA (exact dosages not disclosed)
- DrugMDMA
Comparator MDMA (exact dosages not disclosed)
Location
- Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimore, Maryland