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Evidence suggests MDMA haslittle to no effecton Adverse events.

7 studies (8 claims)

Emerging evidence

Typical effective dose 125 (82.5125) mgacross 3 dosed studies

Study Claims

7 of 8
InterventionDirectionEndpointTypePopulationDosageTitle
MDMA-assisted psychotherapy (MDMA-AT)No effect - no significant difference regarding the incidence≥1 treatment-emergent adverse events (TEAE)
Human
participants with PTSDInactive doses of MDMA (25-40 mg) in the control group; active doses not specified in the abstract.MDMA-assisted psychotherapy for the treatment of PTSD: A systematic review and meta-analysis of randomized controlled trials (RCTs).cited 4×
MDMA-assisted psychotherapyNo effect - No drug-related serious adverse events occurredserious adverse events
Human
patients with treatment-resistant PTSDLow-dose (25 mg plus 12.5 mg supplemental) or full-dose (125 mg plus 62.5 mg supplemental) MDMA administered during three experimental sessions.A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD).cited 226×
MDMA-assisted psychotherapyNo effect - no drug-related serious adverse eventsserious adverse events
Human
people with chronic posttraumatic stress disorder40 mg, 100 mg, and 125 mg administered during eight-hour psychotherapy sessions (two sessions for active doses, with additional open-label sessions).3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.cited 123×
MDMANo effect - was not marked as the primary suspectcardiovascular adverse events
Human
17 cases of cardiovascular AEsNot mentionedConcomitant medications associated with ischemic, hypertensive, and arrhythmic events in MDMA users in FDA adverse event reporting system.cited 3×
MDMANo effect - There were no drug-related serious adverse eventsserious adverse events
Human
patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacologyNot specified in the abstract.The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.cited 373×
MDMADecreases - have been rare and non-life threateningSerious Adverse Events (SAEs)
Human
individuals in clinical trialsNot specified.MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults.cited 58×
MDMANo effect - without the occurrence of unexpected drug-related SAEsSerious Adverse Events (SAEs)
Human
over 1133 individuals for research purposesNot specified.MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults.cited 58×