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Effects of Drugs on Responses to Brain and Emotional Processes

Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04053036
Acronym
MAT
Enrollment
22
Registered
2019-08-12
Start date
2019-08-08
Completion date
2021-04-12
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Healthy

Brief summary

To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits

Interventions

DRUGMDMA

Participants will be given 1.5mg/kg of MDMA

DRUGPlacebo oral tablet

Participants will be given a placebo capsule that will only contain lactose.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Responses to Affective Touch1.5 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo Then MDMA
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) MDMA: Participants will be given 1.5mg/kg of MDMA Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
11
MDMA Then Placebo
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. MDMA: Participants will be given 1.5mg/kg of MDMA Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
11
Total22

Baseline characteristics

CharacteristicPlacebo Then MDMAMDMA Then PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants11 Participants22 Participants
High School Education11 Participants11 Participants22 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants4 Participants
Race (NIH/OMB)
White
8 Participants7 Participants15 Participants
Region of Enrollment
United States
11 participants11 participants22 participants
Sex: Female, Male
Female
4 Participants5 Participants9 Participants
Sex: Female, Male
Male
7 Participants6 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 22
other
Total, other adverse events
0 / 220 / 22
serious
Total, serious adverse events
0 / 220 / 22

Outcome results

Primary

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.

Time frame: 1.5 hrs after drug or placebo administration.

ArmMeasureValue (MEAN)Dispersion
PlaceboChange in Responses to Affective Touch3.01 units on a scaleStandard Deviation 0.7
MDMAChange in Responses to Affective Touch4.06 units on a scaleStandard Deviation 0.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026