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

Phase 4

Not yet recruiting

• Conditions: Deception; Prescription Stimulants; Expectations
• Interventions: Drug: Adderall 10Mg Tablet; Drug: Placebo

• Registration Number: NCT04635826
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Start: 2025-07-01
• Primary Completion: 2029-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo/Deception	Adderall 10Mg Tablet	Participants will be told they are receiving placebo and will actually be administered Adderall
Adderall/Deception	Placebo	Participants will be told they are receiving Adderall and will actually be administered placebo
Adderall/Truth	Adderall 10Mg Tablet	Participants will be told they are receiving Adderall and will actually be administered Adderall.
Placebo/Truth	Placebo	Participants will be told they are receiving placebo and will actually be administered placebo.

Primary Outcome Measures

Name	Time	Method
How expectancy will affect cognitive performance	120 minutes	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.
The impact that stimulants vs. placebo have on the neural circuitry	120 minutes	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.
Determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks	120 minutes	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.