Rachel Yehuda
This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.
This study is investigating the psychological and biological effects and safety of MDMA-assisted therapy (MDMA-AT) in healthy volunteers who are: 1) mental healthcare providers or trainees, and 2) learning or have been certified to conduct MDMA-AT. As research in MDMA-AT expands, there is a need to evaluate the safety and efficacy of MDMA-assisted therapy in healthy volunteers, in order to better understand its effects in populations beyond clinical samples and to inform future comparisons. This study will assess whether a relatively brief intervention (consisting of one MDMA-AT session with o…
Inclusion Criteria: * Are at least 18 years at the time of signing the informed consent. * Fluent in English * Able to swallow pills * Agree to have study visits audiovisually recorded * Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable. * Must be licensed, license-eligible, or trainees in a relevant healthcare/mental health profession * Must be learning or have been certified to conduct MDMA-assisted therapy through the Lykos MDMA-Assiste…
Initial dose of 120 mg MDMA HCl in a therapeutic setting, followed 1.5 to 2 hours later by a supplemental dose of 40 mg MDMA HCl. Supplemental doses may be withheld if tolerability issues emerge or it is declined by the participant.
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