The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

Study Overview
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Brief Summary
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We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.

Detailed Description
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Participants will then be randomized in a balanced placebo design (BPD) crossing medication (10 mg of mixed amphetamine salts vs placebo) and expectancy (told active medication vs placebo medication), resulting in 4 different conditions 1) mixed amphetamine salts/told stimulant medication; 2) placebo/told stimulant medication; 3) mixed amphetamine salts/told placebo; and 4) placebo/told placebo). Participants will be assigned to four scanning sessions scheduled one week apart and will experience each condition once counterbalanced across participants. Participants will be administered cognitive tasks in and out of the scanner to determine the effects of medication vs expectancy.

Official Title
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The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

Conditions
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Prescription Stimulants, Expectations, Deception

Intervention / Treatment
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* Drug: Adderall 10Mg Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-30 years old enrolled as a student at UAB or local college/university if female, willing to use adequate birth control or abstain from sexual activity Exclusion Criteria: current or prior head injury current or prior psychiatric diagnosis (including ADHD) neurological disorder or stroke, hypertension, history of blood or circulation disorders (e.g., anemia or sickle-cell), diabetes, brain or spinal abnormalities blood pressure more than 130 systolic and 80 diastolic heart rate more than 100 beats per minute pregnancy current illicit substance use as well as nicotine use Alcohol or cannabis use that meets DSM-5 criteria for an alcohol or cannabis use disorder Inability to abstain from alcohol or cannabis the night before and day of the scanning session Inability to reduce caffeine intake to less than 100 mg on testing days in heavy caffeine users claustrophobia hearing impairment vision impairment that cannot be corrected by MRI-compatible lenses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 X 2, within-subjects, balanced placebo design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adderall/Truth<br>Participants will be told they are receiving Adderall and will actually be administered Adderall. | Drug: Adderall 10Mg Tablet<br>* Participants will be administered Adderall<br>* Other names: Adderall;|
| Experimental: Adderall/Deception<br>Participants will be told they are receiving Adderall and will actually be administered placebo | Drug: Placebo<br>* Participants will be administered placebo<br>|
| Placebo Comparator: Placebo/Truth<br>Participants will be told they are receiving placebo and will actually be administered placebo. | Drug: Placebo<br>* Participants will be administered placebo<br>|
| Experimental: Placebo/Deception<br>Participants will be told they are receiving placebo and will actually be administered Adderall | Drug: Adderall 10Mg Tablet<br>* Participants will be administered Adderall<br>* Other names: Adderall;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How expectancy will affect cognitive performance | Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. The main outcome measure is how the expectancy of stimulants will affect cognitive performance. | 120 minutes | 
| The impact that stimulants vs. placebo have on the neural circuitry | Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine the impact stimulant administration and expectancy of stimulants have on the neural circuitry that supports sustained attention, inhibitory control, and verbal memory processes. | 120 minutes | 
| Determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks | Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks that support cognitive processes under investigation. | 120 minutes |