Rankings / Mood, Anxiety & Stress
MDMA (3,4-methylenedioxymethamphetamine)
Mood, Anxiety & Stress · Entactogen
Tier C
High-risk evidence profile
Bottom line
Read Off Label grades MDMA (3,4-methylenedioxymethamphetamine) as C (5.1/10) based on moderate evidence, med-high benefit magnitude, and a med-high-risk safety profile.
Its high-risk evidence profile reflects a Safety score of 3.5/10; reported benefits and harms can differ by indication, dose, route, duration, and population.
FDA rejected Lykos (formerly MAPS PBC) NDA for MDMA-AT in PTSD August 2024 — citing functional unblinding, trial design, and therapist sexual misconduct in Ph2.
Studied, labeled, or reported-use context: 80-125 mg PO in clinical protocols; recreational doses highly variable and often adulterated — Schedule I US; expanded access in Australia for PTSD; not individualized guidance.
What the evidence says
FDA rejected Lykos (formerly MAPS PBC) NDA for MDMA-AT in PTSD August 2024 — citing functional unblinding, trial design, and therapist sexual misconduct in Ph2. Lykos required to run new Ph3. Pure MDMA vs street 'ecstasy' (often adulterated/contaminated) is a major harm-reduction issue.
Mechanism
Massive serotonin release via SERT reversal; also dopamine/norepinephrine release; oxytocin release; acute prosocial and empathogenic effects
Studied, labeled, or reported dose & route
80-125 mg PO in clinical protocols; recreational doses highly variable and often adulterated
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
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Common questions
- What does the evidence show about MDMA (3,4-methylenedioxymethamphetamine)'s effects?
- Read Off Label rates the evidence for MDMA (3,4-methylenedioxymethamphetamine) as Moderate and the benefit magnitude as med-high, producing an overall grade of C (5.1/10). FDA rejected Lykos (formerly MAPS PBC) NDA for MDMA-AT in PTSD August 2024 — citing functional unblinding, trial design, and therapist sexual misconduct in Ph2.
- What safety findings are reported for MDMA (3,4-methylenedioxymethamphetamine)?
- MDMA (3,4-methylenedioxymethamphetamine) has a med-high risk profile in the database. Med-High (hyponatremia, hyperthermia, cardiovascular; neurotoxicity concerns with high/repeated doses; serotonin syndrome with MAOIs) Legal status: Schedule I US; expanded access in Australia for PTSD.
- What does the low Safety score for MDMA (3,4-methylenedioxymethamphetamine) represent?
- The Safety score is 3.5/10. It records the substantial harms described for one or more use contexts; the Benefit score, indication, dose, route, duration, population, and legal status remain separate parts of the evidence profile.
- What doses or routes are reported for MDMA (3,4-methylenedioxymethamphetamine)?
- 80-125 mg PO in clinical protocols; recreational doses highly variable and often adulterated This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does MDMA (3,4-methylenedioxymethamphetamine) work?
- Massive serotonin release via SERT reversal; also dopamine/norepinephrine release; oxytocin release; acute prosocial and empathogenic effects
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.