Drugs Brain and Behavior (DDP) (DDP)

Drugs Brain and Behavior

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

Study Overview

• Status: Recruiting
• Conditions: Stimulant Use
• Intervention / Treatment: Drug: Methamphetamine; Drug: placebo oral tablet

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Matthew Bona; Phone Number: 773-702-3560; Email: dewitlab@yoda.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Matthew Bona; Email: dewitlab@yoda.bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 oral tablet; Participants will be given a placebo capsule that will only contain lactose.
Experimental: MethamphetamineThen 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 oral tablet; Participants will be given a placebo capsule that will only contain lactose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Time Frame: Day 1(baseline), 3

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Harriet de Wit, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: IRB20-0364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No