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Also known as 3,4-Methylenedioxymethamphetamine (MDMA)
3, 4-Methylenedioxymethamphetamine · 1 trial · 1 indication
The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity * Combined into a severity score per item * Total score reflects overall PTSD symptom severity
| Arm | Type | Description |
|---|---|---|
| MDMA group | EXPERIMENTAL | - |
| Standard of Care | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 3,4-Methylenedioxymethamphetamine (MDMA) | DRUG | MDMA is a synthetic compound, commonly administered as MDMA hydrochloride (HCl). The drug will be administered in 100mg doses for a single session on Visit 2 out of 10- day study sessions over 2 weeks. MDMA is administered orally in capsule form and is taken under supervision in a controlled, therapeutic environment |
| Placebo | DRUG | Placebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg). |
| Massed Prolonged Exposure (PE) | BEHAVIORAL | Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy. Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework." |
Inclusion Criteria: * PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R). * Able to speak and read English (due to standardization of outcome measures). * Willing to sign a release for the investigators to communicate with their primary ca...
3,4-Methylenedioxymethamphetamine (MDMA) is an investigational small molecule being studied for the treatment of Post Traumatic Stress Disorder (PTSD). It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial.
United Therapeutics Corporation (NASDAQ: UTHR) is developing 3,4-Methylenedioxymethamphetamine (MDMA). The company is conducting a Phase 2 clinical trial of the drug for Post Traumatic Stress Disorder (PTSD). The trial is currently recruiting participants in the United States.
3,4-Methylenedioxymethamphetamine (MDMA) is in Phase 2 clinical development for Post Traumatic Stress Disorder (PTSD). It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is actively recruiting participants.
3,4-Methylenedioxymethamphetamine (MDMA) is being studied in a Phase 2 clinical trial with the identifier NCT07288151, titled "MDMA-Assisted Massed Exposure Therapy for PTSD." The trial is recruiting 200 participants with Post Traumatic Stress Disorder in the United States. It is randomized, double-blind, and placebo-controlled.
Yes, 3,4-Methylenedioxymethamphetamine (MDMA) is also known as MDMA. The drug is being developed by United Therapeutics Corporation for Post Traumatic Stress Disorder (PTSD) and is currently in Phase 2 clinical trials. The ongoing trial, NCT07288151, is recruiting 200 participants in the United States.