Mental Wellbeing
Conditions
Keywords
Psychedelic Therapy, MDMA, MDMA-Assisted Therapy, Mental Health, Therapist
Brief summary
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.
Detailed 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.
Interventions
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.
Sponsors
Rachel Yehuda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental Health Continuum-Short Form (MHC-SF) | At baseline and 28 days post-treatment | The MHC-SF is a self-report measure consisting of 14 questions rated for the frequency at which they are experienced, on a scale from "0-never" to "5-every day" within the past month. The MHC-SF is a shortened version of the Mental Health Continuum Long Form (MHC-LF), a 40-item measure which was developed to assess emotional, social, and psychological well-being, a three factor structure validated in national and international populations. The MHC-SF was developed using a subset of items from the MHC-LF to represent each of these three well-being constructs: The MHC-SF yields a total score range of 0-70, where higher scores reflect greater mental well-being. Subscale ranges are: Emotional Well-Being: 0-15 (3 items), Psychological Well-Being: : 0-30 (6 items), and Social Well-Being: 0-25 (5 items). Subscale scores reflect functioning in each domain, while the total score captures overall mental well-being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Maslach Burnout Inventory - Human Services Survey (MBI-HSS) | At baseline and 28 days post-treatment | The MBI-HSS is a 22-item survey scored from 0-6 per item, producing a total score range of 0-132, where higher scores indicate poorer health outcomes. This 22-item survey addresses 3 scales: Emotional Exhaustion: 0-42, which measures feelings of being emotionally overextended and exhausted by one's work; Depersonalization: 0-42, which measures an unfeeling and impersonal response toward recipients of one's service, care treatment, or instruction; and Personal Accomplishment: 0-48, which measures feelings of competence and successful achievement in one's work. |
Countries
United States
Contacts
CONTACTLily Fischer
STUDY_DIRECTORTamar Glatman Zaretsky
Mount Sinai Icahn School of Medicine
PRINCIPAL_INVESTIGATORRachel Yehuda
Mount Sinai Icahn School of Medicine
Outcome results
None listed