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

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379959

Collaborator

(none)

Enrollment

Location

Arms

13.7

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stimulant Use MDMA ('Ecstasy') Social Behavior Motivation	Drug: MDMA Drug: Methamphetamine Drug: placebo oral tablet	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 11, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: MDMA Participants will be given 125 mg of MDMA. Drug: Methamphetamine Participants will be given 20 mg of MA. Drug: placebo oral tablet Participants will be given a placebo capsule that will only contain lactose.
Experimental: 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.	Drug: MDMA Participants will be given 125 mg of MDMA. Drug: Methamphetamine Participants will be given 20 mg of MA. Drug: placebo oral tablet Participants will be given a placebo capsule that will only contain lactose.
Experimental: 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.	Drug: MDMA Participants will be given 125 mg of MDMA. Drug: Methamphetamine Participants will be given 20 mg of MA. Drug: placebo oral tablet Participants will be given a placebo capsule that will only contain lactose.

Arm

Intervention/Treatment

Experimental: 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.

Drug: MDMA

Participants will be given 125 mg of MDMA.

Drug: Methamphetamine

Participants will be given 20 mg of MA.

Drug: placebo oral tablet

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

Experimental: 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.

Drug: MDMA

Participants will be given 125 mg of MDMA.

Drug: Methamphetamine

Participants will be given 20 mg of MA.

Drug: placebo oral tablet

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

Experimental: 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.

Drug: MDMA

Participants will be given 125 mg of MDMA.

Drug: Methamphetamine

Participants will be given 20 mg of MA.

Drug: placebo oral tablet

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

Outcome Measures

Primary Outcome Measures

Profile of Mood States [Time Frame: Baseline-72 hours after completion of the sessions]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT05379959

Other Study ID Numbers:

IRB21-1568

First Posted:

May 18, 2022

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Methamphetamine

Study Results

No Results Posted as of May 18, 2022