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3, 4 Methylenedioxymethamphetamine · 1 trial · 1 indication
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity.
| Arm | Type | Description |
|---|---|---|
| Dose A (exact dose not disclosed) | EXPERIMENTAL | Non-medicine sessions of PE + One Medicine Session with 3,4-methylenedioxymethamphetamine (MDMA) PE Non-medicine sessions: 12 sessions MDMA Medicine session: Dose: exact dose not disclosed |
| Dose B (exact dose not disclosed) | EXPERIMENTAL | Non-medicine sessions of PE + One Medicine Session with 3,4-methylenedioxymethamphetamine (MDMA) PE Non-medicine sessions: 12 sessions MDMA Medicine session: Dose: exact dose not disclosed |
| Name | Type | Description |
|---|---|---|
| 3,4 Methylenedioxymethamphetamine | DRUG | 1 MDMA session |
| Prolonged Exposure | BEHAVIORAL | 12 90-minute PE sessions; initial two sessions both occurring during the first treatment visit, third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day |
Inclusion Criteria: 1. Be a veteran (age 18-64 years old) who meets criteria for PTSD on the CAPS-5 (severity ≥ 25). 2. Be fluent in speaking and reading English. 3. Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessar...
3,4 Methylenedioxymethamphetamine, also known as MDMA, is being investigated as a treatment for Post-Traumatic Stress Disorder (PTSD). It is in Phase 3 clinical development as an investigational small molecule therapy. The drug is being studied in combination with massed prolonged exposure therapy for PTSD.
3,4 Methylenedioxymethamphetamine targets the serotonin transporter (SERT). By acting on SERT, the drug is believed to modulate serotonin levels in the brain, which may help facilitate the therapeutic process in PTSD treatment. This mechanism is being evaluated in the context of MDMA-assisted psychotherapy.
3,4 Methylenedioxymethamphetamine is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting a Phase 3 clinical trial of the drug for Post-Traumatic Stress Disorder in the United States.
3,4 Methylenedioxymethamphetamine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants with Post-Traumatic Stress Disorder.
3,4 Methylenedioxymethamphetamine is being studied in one Phase 3 clinical trial with the identifier NCT06117306. The trial, titled 'MDMA-assisted Massed Prolonged Exposure for PTSD,' is recruiting 20 participants in the United States. It is a randomized, double-blind, controlled study for Post-Traumatic Stress Disorder.
Yes, 3,4 Methylenedioxymethamphetamine is the same as MDMA. The drug is commonly referred to by its abbreviation MDMA. In clinical research, it is being evaluated as an investigational treatment for Post-Traumatic Stress Disorder.