Overview
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.
Description
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 one preparatory and one integration session) can improve overall mental wellbeing in a healthy sample of mental healthcare providers, while also evaluating its effects on provider burnout, self-assessed counselor efficacy, mood, psychological flexibility, quality of life, and experiential avoidance. In addition, this study supports continued training for new MDMA-AT providers, including the option for their own MDMA experience to expand on their knowledge of the subjective effects and therapeutic potential of MDMA-AT and enhance their qualifications to provide that therapy. Participants will engage in structured preparation, treatment, and follow-up, guided by trained clinical professionals. Assessments will take place throughout the study to monitor mental health outcomes and ensure participant well-being. Participation will consist of: - Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment, and enrollment. - Preparatory Period (1-4 weeks): Preparatory session with study clinicians, baseline assessments. - Treatment Period (2 days): Experimental session (MDMA administered in a controlled therapeutic setting) followed by an integrative session the next day. - Follow-Up Period (up to 4 weeks): Follow-up visit approximately one month after experimental session, outcome assessments, and study termination.
Eligibility
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