Post-Traumatic Stress DisorderPhase 2NCT05455996
MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders
A Phase 2 study testing MDMA in people with Post-Traumatic Stress Disorder and Adjustment Disorders, run by Nautilus Sanctuary at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder, Adjustment Disorders
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2026to Jun 2028
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Were exposed to stressors related to their work in a health care setting or emergency response system
- Are fluent in speaking and reading English.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy sessions.
- Have a contact (relative, spouse, close friend or other Support Person) who is willing and able to be reached by the Sponsor-Investigators in the event of a participant becoming suicidal or unreachable.
- Agree to inform the Sponsor-Investigators within 48 hours of any medical conditions and procedures.
- If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, be driven home after Experimental Sessions, and commit to medication dosing, therapy, and study procedures.
Who cannot join
- Have previously participated in a clinical treatment trial using MDMA.
- Have a past diagnosis of PTSD unrelated to their work in the healthcare or emergency response systems.
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have a history of or a current primary psychotic disorder or bipolar I disorder
- Have a current eating disorder with active purging
- Have current major depressive disorder with psychotic features
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- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate
- Have uncontrolled essential hypertension
- Have a history of ventricular arrhythmia at any time, other than premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.
- Have a marked Baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and >460 ms in females corrected by Fridericia's formula).
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
- Have symptomatic liver disease or have significant liver enzyme elevations.
- Have a history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (kg).
- Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Memoru
Boulder, Colorado, 80302
Marcela Ot'alora, MA, LPC, 303.818.1419, marcela@memoru.us
Marcela Ot'alora, MA, LPC
InnerMost, PBC
New York, New York, 10010
Liana Eisler Study Coordinator, B.A., 917-336-2608, liana@innermost.one
Casey Paleos, MD
The Pearl Institute
Waynesville, North Carolina, 28786
Raymond C Turpin, PsyD, (828) 378-1527, info@pearlpsychedelicinstitute.org
Joel Chisholm, MD
About this study
Official title: An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.
Read the detailed description
After being informed about the study and potential risks, screening participants who sign the Informed Consent form will go through multiple screening visits (onsite and remote) designed to assess psychiatric and medical appropriateness for the study treatment. Tapering of certain medications are required. The screening period takes between 3 to 7 weeks and includes two preparatory sessions (90 minutes each) with the participant's assigned therapy team.
Once a screening participant is deemed eligible for the study, baseline measures of symptomatology are obtained and a third preparatory session is conducted. The participant then enters into the Active Treatment Period which begins with the first of three all-day dosing sessions followed by three 90-minute integration (non-drug) sessions scheduled approximately a week and a half apart. Approximately 3 to 5 weeks after the first dosing session, a second all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. Approximately 3 to 5 weeks after the second dosing session, a third all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. The total time to complete the Active Treatment Phase is between 6 and 16 weeks.
Two to four weeks after the Active Treatment Phase, participants will meet with therapy team for a Treatment Termination Visit during which participants will complete primary outcome measures. Twelve months later, participants will be contacted and asked to repeat study measures to assess durability of effects.
From Screening to Treatment Termination, participation in the study takes between 11 and 33 weeks. Some non-drug sessions can be done remotely at the discretion of the therapy team.
- Being tested
- MDMA
- Medical subject headings
- Stress Disorders, Post-Traumatic, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Also called MDMA-assisted therapy
MDMA-assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy | Experimental | Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions) Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD and is widely used by researchers and clinicians to monitor change during and after a treatment intervention. Participants indicate how much distress they have experienced due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" using a Likert scale ranging from 0 (Not at all) to 4 (Extremely). Items are summed to provide a total severity score (range = 0-80). It takes 5-10 minutes to complete.
Measured: Up to 17 weeks post-enrollment (Baseline)
Secondary outcomes (1)
Change from Baseline on symptoms of Adjustment Disorder based on the Adjustment Disorder New Module-20 (ADNM-20) at Treatment Termination
The ADNM-20 is a 20-item self-report questionnaire that measures AjD symptomatology and has two parts. In the first part, participants go through a list of typical stressors, mark the presence and timing of any that apply, and indicate the one stressor that was the most straining. In the second part, the participant ranks using a 4-point Likert scale, ranging from 1 (never) to 4 (often) the degree to which the most significant stressor may be causing troublesome reactions. The ADNM-20 consists of six subscales: preoccupation (4 items), failure to adapt (4 items), avoidance (4 items), depressive mood (3 items), anxiety (2 items), and impulse disturbance (3 items). ). It takes 5-10 minutes to complete.
Measured: Up to 17 weeks post-enrollment (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open label study to treat symptoms of Post-Traumatic Stress in 30 Frontline Health Care Workers and First Responders using a 3-dosing model of MDMA-assisted therapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nautilus Sanctuary
- Sponsor type
- University, hospital or other
- Collaborators
- Nautilus Psychiatric Services, PLLC
- Responsible party
- Sponsor
- Investigators
- Willa Hall, Ph.D., Study director, Nautilus SanctuaryCasey Paleos, M.D., Principal investigator, InnerMost PBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455996
- Sponsor's protocol ID
- IUSCF1/NSCovid-1
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy
- ClinicalTrials.gov ID
- NCT05455996
- Acronym / sponsor ID
- IUSCF1/NSCovid-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nautilus SanctuaryUniversity, hospital or other
- Collaborators
- Nautilus Psychiatric Services, PLLC
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Jul 2022 (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.
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.
Detailed description
After being informed about the study and potential risks, screening participants who sign the Informed Consent form will go through multiple screening visits (onsite and remote) designed to assess psychiatric and medical appropriateness for the study treatment. Tapering of certain medications are required. The screening period takes between 3 to 7 weeks and includes two preparatory sessions (90 minutes each) with the participant's assigned therapy team.
Once a screening participant is deemed eligible for the study, baseline measures of symptomatology are obtained and a third preparatory session is conducted. The participant then enters into the Active Treatment Period which begins with the first of three all-day dosing sessions followed by three 90-minute integration (non-drug) sessions scheduled approximately a week and a half apart. Approximately 3 to 5 weeks after the first dosing session, a second all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. Approximately 3 to 5 weeks after the second dosing session, a third all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. The total time to complete the Active Treatment Phase is between 6 and 16 weeks.
Two to four weeks after the Active Treatment Phase, participants will meet with therapy team for a Treatment Termination Visit during which participants will complete primary outcome measures. Twelve months later, participants will be contacted and asked to repeat study measures to assess durability of effects.
From Screening to Treatment Termination, participation in the study takes between 11 and 33 weeks. Some non-drug sessions can be done remotely at the discretion of the therapy team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open label study to treat symptoms of Post-Traumatic Stress in 30 Frontline Health Care Workers and First Responders using a 3-dosing model of MDMA-assisted therapy.
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted therapy | Experimental | Drug: MDMAParticipants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Were exposed to stressors related to their work in a health care setting or emergency response system
- Are fluent in speaking and reading English.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy sessions.
- Have a contact (relative, spouse, close friend or other Support Person) who is willing and able to be reached by the Sponsor-Investigators in the event of a participant becoming suicidal or unreachable.
Key exclusion criteria (18 listed)
- Have previously participated in a clinical treatment trial using MDMA.
- Have a past diagnosis of PTSD unrelated to their work in the healthcare or emergency response systems.
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have a history of or a current primary psychotic disorder or bipolar I disorder
- Have a current eating disorder with active purging
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 |
|---|---|---|
| MDMAAlso: MDMA-assisted therapyMDMA-assisted therapy | Drug | MDMA-assisted therapy |
Primary outcome
Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination
Time frame: Up to 17 weeks post-enrollment (Baseline)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD and is widely used by researchers and clinicians to monitor change during and after a treatment intervention. Participants indicate how much distress they have experienced due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" using a Likert scale ranging from 0 (Not at all) to 4 (Extremely). Items are summed to provide a total severity score (range = 0-80). It takes 5-10 minutes to complete.
1 secondary outcome
Change from Baseline on symptoms of Adjustment Disorder based on the Adjustment Disorder New Module-20 (ADNM-20) at Treatment Termination
Time frame: Up to 17 weeks post-enrollment (Baseline)
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Willa Hall, Ph.D. study director
Nautilus Sanctuary
Casey Paleos, M.D. principal investigator
InnerMost PBC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDMA in people with Post-Traumatic Stress Disorder and Adjustment Disorders, run by Nautilus Sanctuary at 3 sites 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 18 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Willa Hall, Ph.D. (9175091497, willa@nautilussanctuary.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination (time frame: Up to 17 weeks post-enrollment (Baseline)). 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 5 May 2026.