University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Completed
NCT Number: NCT03530631
Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year–24 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Adderall
DrugParticipants will be administered Adderall
Placebo
DrugParticipants will be administered placebo
Primary outcomes
-
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
Time frame: A total of 4 imagining sessions, an average of 60 minutes each
Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions.
Sponsors and collaborators
Lead sponsor
University of Alabama at Birmingham
Other
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- May 21, 2018
- Registry last updated
- Dec 16, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.