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Early Phase 1 N=138 Randomized Quadruple-blind Basic Science

Drugs Brain and Behavior (DDP)

Stimulant Use

Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: 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). — 19.2; 57.8; 28.6; 76.3 score on a scale — p=.05

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Methamphetamine (Drug); placebo oral tablet (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Chicago
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
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).
19.2; 57.8; 28.6; 76.3; 25.2; 26.8 .05

Summary

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

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04642820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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