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Home/Research/MDMA/Autism Spectrum Disorder (ASD)

MDMA for Autism Spectrum Disorder (ASD)

12 papers and 4 clinical trials exploring mdma as a treatment for autism spectrum disorder (asd).

Compoundempathogen

MDMA

MDMA is a synthetic empathogen that enhances monoamine release, producing prosocial and anxiolytic effects without frank hallucinosis. Two Phase III trials demonstrated significant PTSD symptom reductions, though FDA review raised concerns about blinding, durability, and safety characterisation.

Full MDMA profile
IndicationApproximately 1 in 160 children worldwide.

Autism Spectrum Disorder (ASD)

Research into the use of psychedelics for treating Autism Spectrum Disorder (ASD) is limited but gaining traction, with preliminary studies suggesting potential therapeutic benefits, particularly for associated social anxiety. Notable figures in this emerging field, such as Alicia Danforth and Charles Grob, are advocating for further exploration of psychedelics in ASD treatment.

Full Autism Spectrum Disorder (ASD) profile

Academic Research

12 papers
Open Accessindividual

Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA

This chemistry paper (2021) outlines a four-step process for synthesizing up to 5kg of MDMA with fully validated cGMP. MDMA is commonly synthesized with safrole, a highly controlled substance. The presented method uses uncontrolled substances achieving results in excess of 99% purity.

Published
December 20, 2021
Journal
ACS Omega
Authors
Nair, J. B., Hakes, L., Yazar-Klosinski, B., Paisner, K.
Open Accessmeta

MDMA-Assisted Therapy as a Means to Alter Affective, Cognitive, Behavioral, and Neurological Systems Underlying Social Dysfunction in Social Anxiety Disorder

This review (2021) explores the potential of MDMA-assisted therapy for treating the various symptoms of social anxiety disorder (SAD). The authors hypothesize how disruptions in neurological, perceptual, receptive, and expressive systems regulating social behavior in SAD may take place as a result of MDMA-assisted therapy, thereby acting as a stimulus for further research.

Published
September 27, 2021
Journal
Frontiers in Psychiatry
Authors
Luoma, J. B., Lear, M. K.
Paywallindividual

Systemic enhancement of serotonin signaling reverses social deficits in multiple mouse models for ASD

This study in mice finds that MDMA (and a selective 5-HT1b receptor agonist) reverse social deficits through increased activity in the nucleus accumbens (NAc). The authors argue that enhancement of 5-HT release or direct 5-HT1b receptor activation may help with treating sociability deficits commonly found in those with autism spectrum disorder (ASD).

Published
July 8, 2021
Journal
Neuropsychopharmacology
Authors
Walsh, J. J., Llorach, P., Cardozo Pinto, D. F., Wenderski, W., Christoffel, D. J., Salgado, J. S., Heifets, B. D., Crabtree, G. R., Malenka, R. C.
Paywallmeta

A Systematic Review of the MDMA Model to Address Social Impairment in Autism

This systematic review finds that postnatal MDMA administration produces prosocial behaviours and may alleviate social impairments in autism models, with the strongest evidence coming from animal studies. Clinical trials are now under way, but larger and longer studies are needed to confirm whether MDMA or MDMA-like compounds can treat social deficits in ASD.

Published
July 1, 2021
Journal
Current Neuropharmacology
Authors
Chaliha, D., Mamo, J. C., Albrecht, M., Lam, V., Takechi, R., Vaccarezza, M.
Open Accessmeta

Modulation of Social Cognition via Hallucinogens and “Entactogens”.

This literature review (2019) discusses controlled experimental studies on the effects of psychedelics (e.g. LSD, psilocybin, MDMA) on social cognition and behavior to treat disorders characterized by social dysfunctions such as depression, post-traumatic stress disorder (PTSD), anxiety, and autism spectrum disorders (ASD). It also discusses persisting knowledge gaps into sex-specific drug effects and objective data on social behavior within the framework of MDMA- and hallucinogen-assisted therapy. The study suggests hallucinogen-based treatment methods and the development of novel medication for trans-diagnostic dysfunction in social cognition and noted that entactogens and hallucinogens have consistently shown prosocial effects and have identified alterations in social processing and behavior as major factors for the efficacy of treatments involving them.

Published
December 3, 2019
Journal
Frontiers in Psychiatry
Authors
Preller, K. H., Vollenweider, F. X.
Paywallindividual

Sensitization to the prosocial effects of 3,4-methylenedioxymethamphetamine (MDMA)

This mouse study investigated the mechanisms behind sensitisation to the prosocial effects of MDMA (7.8 mg/kg). It finds that repeated administration led to increased social interaction, a process dependent on social context and 5-HT2A receptor activation during the development, but not the expression, of this sensitisation.

Published
June 1, 2019
Journal
Neuropharmacology
Authors
Curry, D. W., Berro, L. F., Belkoff, A. R., Sulima, A., Rice, K. C., Howell, L. L.

Clinical Trials

4 trials
Not yet recruitingPhase NA

Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients With Autism Spectrum Disorder and Matched Healthy Controls

This randomised, double-blind, crossover interventional trial (n=40) will assess whether a single 100 mg dose of MDMA changes circulating oxytocin signalling differently in adults with autism spectrum disorder (ASD) and matched healthy controls. The study (OxySPECTRUM) is designed to explore the physiological oxytocin response to MDMA, using plasma neurophysin I as an equimolar surrogate marker for oxytocin. Participants in both the ASD and healthy control groups will receive MDMA 100 mg and placebo in within-subject comparisons over two experimental visits, with the order randomised. MDMA will be given as four 25 mg gelatine capsules, while placebo will be identical capsules containing mannitol only. The main outcome is change in the area under the concentration-time curve for plasma neurophysin I from baseline to 5 hours after dosing.

Started
June 1, 2026
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT07555132
RecruitingPhase II

A Phase 2A Trial of MM402 for Autism Spectrum Disorder

This Phase II, open-label trial (n=20) will evaluate the effects of a single administration of MM402, the R-enantiomer of MDMA, in adults aged 18 to 45 with Autism Spectrum Disorder (ASD). The primary aim is to assess changes in social responsiveness and communication deficits, as measured by an 11-point Numerical Rating Scale (NRS) at various time points post-dose. The study will include approximately twenty participants diagnosed with ASD who exhibit clinically significant deficits in socialisation and communication. Participants will receive a single dose of 200 mg MM402, with assessments occurring at baseline, pre-dose, and at 2, 4, 6, 8, and 24 hours post-dose, as well as on day 15. The trial will exclude individuals with certain eye movement abnormalities, a history of psychotic or bipolar disorders, current substance use disorders, or any clinically significant unstable illness. The study is sponsored by Definium Therapeutics US, Inc., with an estimated start date in December 2025 and completion anticipated by August 2027.

Started
December 3, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07303907
CompletedPhase I

Effects of Drugs on Responses to Brain and Emotional Processes

Randomized, triple-blind, crossover study (n=22) testing single oral MDMA 1.5 mg/kg versus placebo on affective touch responses across a range of autistic traits.

Started
August 8, 2019
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT04053036
CompletedPhase II

Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

This double-blind, randomized, placebo-controlled exploratory pilot study assessed the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for social anxiety in MDMA-naïve adults on the autism spectrum.

Started
January 2, 2014
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT02008396

Explore further

Search all MDMA papers Search all Autism Spectrum Disorder (ASD) trials Full MDMA profile Full Autism Spectrum Disorder (ASD) profile