Stimulant Use
Conditions
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.
Interventions
DRUGMethamphetamine
Participants will be given 20 mg of Methamphetamine.
DRUGplacebo oral tablet
Participants will be given a placebo capsule that will only contain lactose.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Methamphetamine: Participants will be given 20 mg of Methamphetamine.
placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose. | 57 |
| 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.
Methamphetamine: Participants will be given 20 mg of Methamphetamine.
placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose. | 56 |
| Total | 113 |
Baseline characteristics
| Characteristic | Placebo Then Methamphetamine | Total | MethamphetamineThen Placebo |
|---|---|---|---|
| Age, Continuous | 24.3 years STANDARD_DEVIATION 4.3 | 24.8 years STANDARD_DEVIATION 4 | 25.3 years STANDARD_DEVIATION 3.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 20 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) White | 32 Participants | 60 Participants | 28 Participants |
| Region of Enrollment United States | 57 participants | 113 participants | 56 participants |
| Sex: Female, Male Female | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Male | 29 Participants | 57 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 56 |
| other Total, other adverse events | 0 / 57 | 0 / 56 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 |
Outcome results
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).
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: Time Frame: Day 1(baseline), 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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). | DEQ Like - Change from baseline | 28.6 score on a scale | Standard Deviation 28 |
| Placebo | 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). | DEQ High - Change from baseline | 13.9 score on a scale | Standard Deviation 19.4 |
| Placebo | 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). | DEQ Dislike - Change from baseline | 25.2 score on a scale | Standard Deviation 28.7 |
| Placebo | 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). | DEQ Want more - Change from baseline | 22.3 score on a scale | Standard Deviation 28.1 |
| Placebo | 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). | DEQ Feel - Change from baseline | 19.2 score on a scale | Standard Deviation 21.6 |
| Methamphetamine | 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). | DEQ Want more - Change from baseline | 69.1 score on a scale | Standard Deviation 28.7 |
| Methamphetamine | 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). | DEQ Feel - Change from baseline | 57.8 score on a scale | Standard Deviation 25.7 |
| Methamphetamine | 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). | DEQ Like - Change from baseline | 76.3 score on a scale | Standard Deviation 26.5 |
| Methamphetamine | 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). | DEQ Dislike - Change from baseline | 26.8 score on a scale | Standard Deviation 25.8 |
| Methamphetamine | 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). | DEQ High - Change from baseline | 48.7 score on a scale | Standard Deviation 29.4 |
p-value: 0.05t-test, 2 sided