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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNautilus Sanctuary

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MDMA

    Drug

    MDMA-assisted therapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: MDMA-assisted therapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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.

Time frame
Up to 17 weeks post-enrollment (Baseline)

Other outcomes

Sponsors and contacts

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Nautilus Sanctuary

Lead sponsor

Nautilus Psychiatric Services, PLLC

Collaborator

This trial is not recruiting at the moment. You can still explore other options: