Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function

NCT ID: NCT05379959

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-10-24

Brief Summary

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To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers

Detailed Description

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Conditions

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Stimulant Use MDMA ('Ecstasy') Social Behavior Motivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental: Placebo Then MDMA Then Methamphetamine

Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

Participants will be given 125 mg of MDMA.

Methamphetamine

Intervention Type DRUG

Participants will be given 20 mg of MA.

placebo oral tablet

Intervention Type DRUG

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

Experimental: MDMA Then Placebo Then Methampetamine

Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

Participants will be given 125 mg of MDMA.

Methamphetamine

Intervention Type DRUG

Participants will be given 20 mg of MA.

placebo oral tablet

Intervention Type DRUG

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

Experimental: Methampetamine Then Placebo Then MDMA

Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

Participants will be given 125 mg of MDMA.

Methamphetamine

Intervention Type DRUG

Participants will be given 20 mg of MA.

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 125 mg of MDMA.

Intervention Type DRUG

Methamphetamine

Participants will be given 20 mg of MA.

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

18 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

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB21-1568

Identifier Type: -

Identifier Source: org_study_id

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