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NCT04635826 | NOT YET RECRUITING | Prescription Stimulants

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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Karen Cropsey

Brief Summary:

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

Condition or disease

Prescription Stimulants

Expectations

Deception

Intervention/treatment

Adderall 10Mg Tablet

Placebo

Phase

PHASE4

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
Estimated Enrollment : 100 participants
Masking : DOUBLE
Masking Description : 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.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2029-07-31
Estimated Study Completion Date : 2030-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

Location Details

NCT04635826

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