Drugs Brain and Behavior (DDP)

NCT04642820 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: IRB20-0364R01DA002812
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Stimulant Use

Outcome Measures

Primary Outcomes (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).

  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

Study Arms (2)

Placebo Then Methamphetamine

EXPERIMENTAL

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; Drug: placebo oral tablet

MethamphetamineThen Placebo

EXPERIMENTAL

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; Drug: placebo oral tablet

Interventions

Methamphetamine DRUG

Participants will be given 20 mg of Methamphetamine.

MethamphetamineThen Placebo; Placebo Then Methamphetamine

placebo oral tablet DRUG

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

MethamphetamineThen Placebo; Placebo Then Methamphetamine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Harriet de Wit, Principal Investigator
• Organization: University of Chicago

hdew@uchicago.edu

773-702-1234

Study Officials

• Harriet de Wit

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2023-12

Locations

US (1)