Clinical trial NCT03530631: Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
Official title: Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Expectancy Versus Pharmacotherapy Effect of Adderall
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
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: The purpose of this balanced-placebo design study is to pilot a larger study to further explore the current evidence that stimulant medications are not cognitive enhancers, despite this rampant belief in young adults. While the lack of cognitive enhancement from stimulant medication has been documented in prior research, this study is the first to utilize neuroimaging technology to examine brain regions activated during neurocognitive tasks when participants believe they have been administered stimulant medication or placebo.

Detailed description: This is a 2 X 2 within subjects, balanced placebo design and all participants will experience each of the four conditions during four sequential weeks. Medication administered (Adderall vs. placebo) is crossed with instructional set (truth vs. deception) and participants' performance on neurocognitive tasks is compared across these groups. For example, participants are either given stimulant medication or placebo, and are either accurately told or inaccurately told that they received stimulant medication or placebo. Neuroimaging is being utilized to investigate whether participants' expectations regarding the benefits of stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the study is that participants' expectations regarding stimulant medication will affect their performance on neurocognitive tasks, rather than the actual effect of the medication.

Eligibility criteria: Inclusion Criteria:

* Age (18-24)
* College student with at least average IQ
* Willingness to standardize caffeine intake to 100 mg on day of study

Exclusion Criteria:

* Attention Deficit/Hyperactivity Disorder (ADHD)
* First degree relative with ADHD
* Unwillingness to comply with caffeine specifications
* Regular use of Adderall
* Pregnant/breastfeeding
* History of substance use disorders
* Illicit stimulant use within the last year
* Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
* Uncontrolled medical illness
* Active contagious infection

Primary outcomes:
measure: Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
timeFrame: A total of 4 imagining sessions, an average of 60 minutes each
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen Cropsey, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: