Early Phase 1 N=22 Randomized Triple-blind Basic Science

Effects of Drugs on Responses to Brain and Emotional Processes

Autism Spectrum Disorder · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04053036 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Change in Responses to Affective Touch — 3.01; 4.06 units on a scale

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: MDMA (Drug); Placebo oral tablet (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Responses to Affective Touch	3.01; 4.06	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04053036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.