An Early Phase 1 interventional study of MDMA and Placebo oral tablet in Autism Spectrum Disorder and Healthy, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by University of Chicago · Early Phase 1, Interventional, and Basic science
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 22 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: MDMA · Drug: Placebo oral tablet
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.
Drug: MDMA · Drug: Placebo oral tablet
Participants will be given 1.5mg/kg of MDMA
Participants will be given a placebo capsule that will only contain lactose.
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.
| Milestone | Placebo Then MDMA | MDMA Then Placebo |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 11 |
| Not completed | 0 | 0 |
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.
| units on a scale | Placebo | MDMA |
|---|---|---|
| Change in Responses to Affective Touch | 3.01 ± .7 | 4.06 ± .5 |
Collected over .Through study completion, an average of 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| MDMA | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Placebo Then MDMA | MDMA Then Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo Then MDMA | MDMA Then Placebo | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 7 | 6 | 13 |
| Race (NIH/OMB)(Participants) | Placebo Then MDMA | MDMA Then Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 7 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(participants) | Placebo Then MDMA | MDMA Then Placebo | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
| High School Education(Participants) | Placebo Then MDMA | MDMA Then Placebo | Total |
|---|---|---|---|
| Count of participants | 11 | 11 | 22 |
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Chicago