Mental WellbeingPhase 1NCT07102576
MDMA-Assisted Therapy for Mental Healthcare Providers
A Phase 1 study testing MDMA Hydrochloride in people with Mental Wellbeing, run by Rachel Yehuda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing
- What is being tested?
- MDMA Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to 21 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Parsons Research Center for Psychedelic Healing
New York, New York, 10025
Tamar Glatman Zaretsky, PsyD, (914) 340-3669, tamar.glatmanzaretsky@mssm.edu
Lily Fischer, MSc, (862) 253-1938, therapistwellbeing@mssm.edu
About this study
Official title: A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy When Administered to Mental Health Providers in Training to be MDMA-Assisted Therapists
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.
Read the 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.
- Conditions
- Mental Wellbeing
- Being tested
- MDMA Hydrochloride
- Keywords
- Psychedelic Therapy, MDMA, MDMA-Assisted Therapy, Mental Health, Therapist
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMA HydrochlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Experimental | One session of MDMA-Assisted Therapy Receives: Drug: MDMA Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Continuum-Short Form (MHC-SF)
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.
Measured: At baseline and 28 days post-treatment
Secondary outcomes (1)
The Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
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.
Measured: At baseline and 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start11 Feb 2026
- Primary completion21 Sep 2029 (estimated)
- Study completion21 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel Yehuda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Yehuda, Icahn School of Medicine at Mount Sinai
- Investigators
- Tamar Glatman Zaretsky, Study director, Mount Sinai Icahn School of MedicineRachel Yehuda, Principal investigator, Mount Sinai Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102576
- Sponsor's protocol ID
- STUDY-24-00412
- Status last verified
- Feb 2026
- First submitted
- 31 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans at this time
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy When Administered to Mental Health Providers in Training to be MDMA-Assisted Therapists
- ClinicalTrials.gov ID
- NCT07102576
- Acronym / sponsor ID
- STUDY-24-00412
- Conditions
- Mental Wellbeing
- Keywords
- Psychedelic Therapy, MDMA, MDMA-Assisted Therapy, Mental Health, Therapist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rachel YehudaUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 21 Sep 2029 (estimated)
- Study completion
- 21 Dec 2029 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Experimental | Drug: MDMA HydrochlorideOne session of MDMA-Assisted Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDMA HydrochlorideInitial 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. | Drug | Open-Label |
Primary outcome
Mental Health Continuum-Short Form (MHC-SF)
Time frame: 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.
1 secondary outcome
The Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Time frame: At baseline and 28 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. No plans at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamar Glatman Zaretsky study director
Mount Sinai Icahn School of Medicine
Rachel Yehuda principal investigator
Mount Sinai Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDMA Hydrochloride in people with Mental Wellbeing, run by Rachel Yehuda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily Fischer (862-253-1938, therapistwellbeing@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Continuum-Short Form (MHC-SF) (time frame: At baseline and 28 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.