MDMA-Assisted Therapy for Stress Disorders in... — Clinical Trial Details

This single-group, open-label Phase II study evaluates safety and efficacy of MDMA-assisted therapy in health-care workers with work-related post-traumatic stress following the COVID-19 pandemic.

Participants complete screening and three preparatory sessions, then receive three all-day MDMA dosing sessions spaced ~3–5 weeks apart; each dosing is followed by three 90-minute integration sessions.

Outcome assessments occur at treatment termination 2–4 weeks after active treatment and again at 12 months to assess durability; safety monitoring includes medication tapering and medical screening during enrollment.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

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

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 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, hypokalaemia, 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 hyponatraemia or hyperthermia
Weigh less than 48 kilograms
Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control

Company

Product

Legal

MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions