MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders

NCT05455996 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IUSCF1/NSCovid-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Post-Traumatic Stress Disorder; Adjustment Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 17 weeks post-enrollment (Baseline)

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions)

Drug: MDMA

Interventions

MDMA DRUG

MDMA-assisted therapy

Also known as: MDMA-assisted therapy

MDMA-assisted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Nautilus Psychiatric Services, PLLC: collaborator
• Nautilus Sanctuary: lead

Study Sites (3)

Memoru

Boulder, Colorado, 80302, United States

Location

InnerMost, PBC

New York, New York, 10010, United States

Location

The Pearl Institute

Waynesville, North Carolina, 28786, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Adjustment Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Willa Hall, Ph.D.

  Nautilus Sanctuary

  STUDY DIRECTOR

• Casey Paleos, M.D.

  InnerMost PBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willa Hall, Ph.D.

CONTACT

9175091497; willa@nautilussanctuary.org

Casy Paleos, M.D.

CONTACT

6316371953; casey@innermost.one

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 13, 2022
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)