Could a modified MDMA ease autism symptoms? small trial begins
NCT ID NCT07303907
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests a drug called DT402 (a form of MDMA) in 20 adults with autism spectrum disorder. The goal is to see if it can reduce the severity of social and communication problems. Participants will take the drug and report their experiences using simple rating scales. It is an early, open-label trial, meaning everyone knows they are getting the drug, so results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DT402 (R-MDMA, a form of MDMA)
- What this could lead to
- If it works, this could point toward a new treatment to help adults with autism feel less severe social and communication difficulties.
- What could go wrong
- This is a very small, early-phase trial with only 20 people and no placebo group, so results may not be reliable or apply to everyone. The drug is psychoactive and may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition) 2. Male or Female aged 18 to 65 3. Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66 Exclusion Criteria: 1. Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. Any clinically significant unstable illness
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spectrum Neuroscience and Treatment Institute
RECRUITINGNew York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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