Effects of Drugs on Responses to Brain and Emotional Processes

NCT04053036 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB19-0174
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1.5 hrs after drug or placebo administration.

Study Arms (2)

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)

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.

Drug: MDMA; Drug: Placebo oral tablet

Interventions

MDMA DRUG

Participants will be given 1.5mg/kg of MDMA

MDMA Then Placebo; Placebo Then MDMA

Placebo oral tablet DRUG

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

MDMA Then Placebo; Placebo Then MDMA

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Harriet de Wit

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: August 8, 2019
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)