Phase 4 N=4 Randomized Double-blind Health Services Research

Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Expectancy Versus Pharmacotherapy Effect of Adderall

Bottom Line

View on ClinicalTrials.gov: NCT03530631 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions — 4; 4; 4; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Adderall (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions	4; 4; 4; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03530631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.