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

NCT04635826 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 300006362
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prescription Stimulants; Expectations; Deception

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Adderall/Truth

EXPERIMENTAL

Participants will be told they are receiving Adderall and will actually be administered Adderall.

Drug: Adderall 10Mg Tablet

Adderall/Deception

EXPERIMENTAL

Participants will be told they are receiving Adderall and will actually be administered placebo

Drug: Placebo

Placebo/Truth

PLACEBO COMPARATOR

Participants will be told they are receiving placebo and will actually be administered placebo.

Drug: Placebo

Placebo/Deception

EXPERIMENTAL

Participants will be told they are receiving placebo and will actually be administered Adderall

Drug: Adderall 10Mg Tablet

Interventions

Adderall 10Mg Tablet DRUG

Participants will be administered Adderall

Also known as: Adderall

Adderall/Truth; Placebo/Deception

Placebo DRUG

Participants will be administered placebo

Adderall/Deception; Placebo/Truth

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Deception

Interventions

Adderall; Tablets

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Karen Cropsey, PsyD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• David Knight, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-blind study. Research assistants will administer capsules, and based on package labeling, tell the participant if they are being administered Adderall or placebo. However, researchers and participants will be blind to which medication is actually being administered.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 2 X 2, within-subjects, balanced placebo design

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 19, 2020
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 7, 2025

Record last verified: 2025-04