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MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05455996
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Willa Hall, Nautilus Sanctuary

Tracking Information
First Submitted Date  ICMJE July 10, 2022
First Posted Date  ICMJE July 13, 2022
Last Update Posted Date July 13, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2022)
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 13 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2022)
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 13 weeks post-enrollment (Baseline) ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers
Official Title  ICMJE An Open Label Study to Treat Post-Traumatic Stress in COVID-19 Healthcare Workers Using MDMA-Assisted Therapy
Brief Summary The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Health Care Workers suffering from symptoms of Post-Traumatic Stress due to their work on the frontline of the COVID Pandemic.
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 two 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. The total time to complete the Active Treatment Phase is between 4 and 9 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. Six 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 9 and 27 weeks. Some non-drug sessions can be done remotely at the discretion of the therapy team.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single-arm, open label study to treat symptoms of Post-Traumatic Stress in 30 Health Care Workers using a 2-dosing model of MDMA-assisted therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-Traumatic Stress Disorder
  • Adjustment Disorders
Intervention  ICMJE Drug: MDMA
MDMA-assisted therapy
Study Arms  ICMJE Experimental: MDMA-assisted therapy
Participants will receive 2-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions)
Intervention: Drug: MDMA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Were exposed to stressors related to their work in a health care setting during the COVID-19 pandemic
  • Live full-time within a 60-mile radius of New York City.
  • 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.

Exclusion Criteria:

  • Have previously participated in a clinical treatment trial using MDMA.
  • Have a past diagnosis of PTSD unrelated to the COVID-19 pandemic.
  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Willa Hall, Ph.D. 9175091497 willa@nautilussanctuary.org
Contact: Casy Paleos, M.D. 6316371953 cpaleos@mdma.nyc
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05455996
Other Study ID Numbers  ICMJE IUSCF1/NSCovid-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Willa Hall, Nautilus Sanctuary
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Willa Hall
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nautilus Sanctuary
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP