DEG: Brain Function and EEG

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05003076
Collaborator
(none)
30
1
2
33
0.9

Study Details

Study Description

Brief Summary

In this project, we will examine effects of MA on reward function using electroencephalograms (EEG), which will complement our ongoing study with MA and fMRI. We will determine how MA alters reward-related neural activity and how this is related to its subjective rewarding effects. The effects of MA on reward function will be examined using both reward-task-related activation and resting state activity. We will examine the effects of MA on ratings of drug liking and euphoria, as well as on EEG measures sensitivity to reward. Healthy young adults will undergo three EEG sessions with placebo and MA (10 and 20 mg), while performing the Monetary Incentive Delay task and the Stop Task, as a measure of inhibition. We will examine correlations between the neural responses and subjective responses to MA.

Our central hypotheses are 1) that MA will increase feelings of alertness and well-being, and 2) that MA will increase neural responses to anticipation and receipt of reward, and 3) that the effects of MA on mood will be correlated with its effects on neural responses to reward.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Drug Effects on EEG
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Placebo Then Methamphetamine

Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.

Drug: Methamphetamine
Participants will be given 20 mg of Methamphetamine.

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

Experimental: Methamphetamine Then Placebo

Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.

Drug: Methamphetamine
Participants will be given 20 mg of Methamphetamine.

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

Outcome Measures

Primary Outcome Measures

  1. Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). [Time Frame: Day 1(baseline), 3]

    Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

BMI between 19 and 26 Less than 4 alcohol or caffeinated beverages a day.

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

  • Principal Investigator: Harriet de Wit, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT05003076
Other Study ID Numbers:
  • IRB21-0769
First Posted:
Aug 12, 2021
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022