Drugs Brain and Behavior (DDP)

Early Phase 1

Completed

• Conditions: Stimulant Use
• Interventions: Drug: Methamphetamine; Drug: placebo oral tablet

• Registration Number: NCT04642820
• Lead Sponsor: University of Chicago

Brief Summary

In this project, we will examine individual differences in the effects of a stimulant drug, methamphetamine (MA), on mesolimbic reward function using fMRI.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Primary Completion: 2023-10-01
• Status Verified: 2023-12
• Study Completion: 2024-06-01
• Results First Submitted: 2024-12-02
• Results First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• BMI between 19 and 26
• Right Handed
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Then Methamphetamine	placebo oral tablet	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.
MethamphetamineThen Placebo	placebo oral tablet	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.
Placebo Then Methamphetamine	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.
MethamphetamineThen Placebo	Methamphetamine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States