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Drugs Brain and Behavior (DDP)

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04642820
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
41
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Drugs Brain and Behavior
Actual Study Start Date :
Nov 1, 2020
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 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.

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

  • 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.

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, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04642820
Other Study ID Numbers:
  • IRB20-0364
First Posted:
Nov 24, 2020
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:
Methamphetamine

Study Results

No Results Posted as of May 20, 2022