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

NCT05379959 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB21-1568
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stimulant Use; MDMA ('Ecstasy'); Social Behavior; Motivation

Outcome Measures

Primary Outcomes (1)

• Profile of Mood States

  The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

  Time Frame: Baseline-72 hours after completion of the sessions

Study Arms (3)

Experimental: Placebo Then MDMA Then Methamphetamine

EXPERIMENTAL

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.

Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet

Experimental: MDMA Then Placebo Then Methampetamine

EXPERIMENTAL

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.

Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet

Experimental: Methampetamine Then Placebo Then MDMA

EXPERIMENTAL

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.

Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet

Interventions

MDMA DRUG

Participants will be given 125 mg of MDMA.

Experimental: MDMA Then Placebo Then Methampetamine; Experimental: Methampetamine Then Placebo Then MDMA; Experimental: Placebo Then MDMA Then Methamphetamine

Methamphetamine DRUG

Participants will be given 20 mg of MA.

Experimental: MDMA Then Placebo Then Methampetamine; Experimental: Methampetamine Then Placebo Then MDMA; Experimental: Placebo Then MDMA Then Methamphetamine

placebo oral tablet DRUG

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

Experimental: MDMA Then Placebo Then Methampetamine; Experimental: Methampetamine Then Placebo Then MDMA; Experimental: Placebo Then MDMA Then Methamphetamine

Eligibility Criteria

• Age: 18 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

Social Behavior

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Methamphetamine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 11, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)