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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Expectations; Prescription Stimulants; Deception
• Intervention / Treatment: Drug: Adderall 10Mg Tablet; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Keith Chichester, M.A.; Phone Number: 205-975-7809; Email: kchichester@uabmc.edu
• Study Contact Backup: Name: Sofia Mildrum Chana, B.A.; Phone Number: 205-975-7809; Email: smildrumchana@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adderall/Truth; Participants will be told they are receiving Adderall and will actually be administered Adderall.	Drug: Adderall 10Mg Tablet; Participants will be administered Adderall; Other Names: Adderall
Experimental: Adderall/Deception; Participants will be told they are receiving Adderall and will actually be administered placebo	Drug: Placebo; Participants will be administered placebo
Placebo Comparator: Placebo/Truth; Participants will be told they are receiving placebo and will actually be administered placebo.	Drug: Placebo; Participants will be administered placebo
Experimental: Placebo/Deception; Participants will be told they are receiving placebo and will actually be administered Adderall	Drug: Adderall 10Mg Tablet; Participants will be administered Adderall; Other Names: Adderall

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: David Knight, PhD, University of Alabama at Birmingham; Principal Investigator: Karen Cropsey, PsyD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Stimulants; Adderall
• Other Study ID Numbers: 300006362

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No