Clinical trial NCT04635826: The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically
Official title: The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Prescription Stimulants
Expectations
Deception
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 X 2, within-subjects, balanced placebo design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: How expectancy will affect cognitive performance
timeFrame: 120 minutes
measure: The impact that stimulants vs. placebo have on the neural circuitry
timeFrame: 120 minutes
measure: Determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen Cropsey, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: David Knight, PhD
role: PRINCIPAL_INVESTIGATOR
References: