Autism Spectrum DisorderEarly Phase 1MATNCT04053036
Effects of Drugs on Responses to Brain and Emotional Processes
A Early Phase 1 study testing MDMA in people with Autism Spectrum Disorder and Healthy, run by University of Chicago at 1 site in United States.
Trial summary
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Healthy
- What is being tested?
- MDMA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 12 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 19 and 30 (no one under 130 lbs)
- Smokers smoking less than 25 cigarettes per week
- Have used ecstasy no more than 40 times with no adverse responses.
Who cannot join
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Individuals with a history of dependence on stimulant drugs.
- Women who are pregnant or trying to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits
- Conditions
- Autism Spectrum Disorder, Healthy
- Being tested
- MDMA, Placebo oral tablet
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Participants will be given 1.5mg/kg of MDMA
Placebo oral tabletDrug
Participants will be given a placebo capsule that will only contain lactose.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Then MDMA | Experimental | Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg) Receives: Drug: MDMA; Drug: Placebo oral tablet |
| MDMA Then Placebo | Experimental | Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo. Receives: Drug: MDMA; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Responses to Affective Touch
Participants will complete an affective touch task during which time they will rate pleasantness of touch on a scale of -10 to +10 using an analog scale. Higher ratings indicate greater pleasantness.
Measured: 1.5 hrs after drug or placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start8 Aug 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053036
- Sponsor's protocol ID
- IRB19-0174
- Acronym
- MAT
- Status last verified
- Jan 2024
- First submitted
- 8 Aug 2019
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits
- ClinicalTrials.gov ID
- NCT04053036
- Acronym / sponsor ID
- MAT / IRB19-0174
- Conditions
- Autism Spectrum Disorder, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Then MDMA | Experimental | Drug: MDMA, Drug: Placebo oral tabletParticipants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg) |
| MDMA Then Placebo | Experimental | Drug: MDMA, Drug: Placebo oral tabletParticipants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 19 and 30 (no one under 130 lbs)
- Smokers smoking less than 25 cigarettes per week
- Have used ecstasy no more than 40 times with no adverse responses.
Key exclusion criteria (5 listed)
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Individuals with a history of dependence on stimulant drugs.
- Women who are pregnant or trying to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDMAParticipants will be given 1.5mg/kg of MDMA | Drug | MDMA Then Placebo, Placebo Then MDMA |
| Placebo oral tabletParticipants will be given a placebo capsule that will only contain lactose. | Drug | MDMA Then Placebo, Placebo Then MDMA |
Primary outcome
Change in Responses to Affective Touch
Time frame: 1.5 hrs after drug or placebo administration.
Participants will complete an affective touch task during which time they will rate pleasantness of touch on a scale of -10 to +10 using an analog scale. Higher ratings indicate greater pleasantness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet de Wit principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MDMA in people with Autism Spectrum Disorder and Healthy, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Responses to Affective Touch (time frame: 1.5 hrs after drug or placebo administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.