About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
MDMA
DrugMDMA-assisted therapy
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Nautilus Sanctuary
Lead sponsor
Nautilus Psychiatric Services, PLLC
Collaborator
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