Effects of Drugs on Responses to Brain and Emotional Processes

NCT ID: NCT04053036

Last Updated: 2024-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2021-04-12

Brief Summary

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

Detailed Description

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Conditions

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Autism Spectrum Disorder Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

Participants will be given 1.5mg/kg of MDMA

Placebo oral tablet

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

Participants will be given 1.5mg/kg of MDMA

Placebo oral tablet

Intervention Type DRUG

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

Interventions

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MDMA

Participants will be given 1.5mg/kg of MDMA

Intervention Type DRUG

Placebo oral tablet

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harriet de Wit

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB19-0174

Identifier Type: -

Identifier Source: org_study_id

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