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

Expectations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04635826
• Other study ID #: 300006362
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2025
• Est. completion date: July 31, 2030

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Keith Chichester, M.A.
• Phone: 205-975-7809
• Email: kchichester[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2030
• Est. primary completion date: July 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Deception
• Expectations
• Prescription Stimulants

Intervention

Drug:
• Adderall 10Mg Tablet
Participants will be administered Adderall
• Placebo
Participants will be administered placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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