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MDMA · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| MDMA-assisted therapy | EXPERIMENTAL | Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions) |
| Name | Type | Description |
|---|---|---|
| MDMA | DRUG | MDMA-assisted therapy |
Inclusion Criteria: * 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 session...
MDMA is an investigational small molecule being studied for Post-Traumatic Stress Disorder (PTSD). It is in Phase 2 clinical development as MDMA-assisted therapy for stress disorders, including PTSD and adjustment disorders, in healthcare workers and first responders. The drug is not approved and remains under clinical investigation.
MDMA targets the serotonin transporter (SERT). By interacting with SERT, it is thought to modulate serotonin signaling, which may underlie its potential therapeutic effects in Post-Traumatic Stress Disorder. This mechanism is being evaluated in the context of MDMA-assisted therapy for stress-related conditions.
MDMA is being developed by Nautilus Biotechnology, Inc., a company traded under the ticker NAUT. The company is conducting clinical research on MDMA-assisted therapy for Post-Traumatic Stress Disorder and related stress conditions in healthcare workers and first responders.
MDMA is in Phase 2 clinical development. It is being studied in an ongoing Phase 2 trial for Post-Traumatic Stress Disorder and adjustment disorders. The drug is investigational and has not been approved by regulatory authorities for any use.
MDMA is being studied in one Phase 2 clinical trial, identified as NCT05455996, titled "MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders." The trial is not yet recruiting and aims to enroll 30 participants in the United States with PTSD or adjustment disorders.