💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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-Assisted Therapy Training program or authorized affiliate program
* Body weight of at least 45 kilograms (kg; or 100 pounds (lbs)).
Exclusion Criteria
* Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment
* Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment
* Have a substance use disorder of any severity within 12 months prior to enrollment
* Any suicidal ideation within the last 6 months
* Repetitive or recent use of Ecstasy/MDMA
* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician
* Meet diagnostic criteria for a Major Depressive Episode currently or within the prior 3 months or meet diagnostic criteria for a current anxiety disorder assessed
* Have a current eating disorder with compensatory behaviors
* Have a history of, or a current primary psychotic disorder or bipolar disorder
* Previous participation in a clinical trial that included administration of MDMA
* Individuals in a personal relationship with the site investigator
* Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception
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