Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Expectancy Versus Pharmacotherapy Effect of Adderall Clinical Trial

Official title:

Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530631
• Other study ID #: IRB-300000343
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: December 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Expectancy Versus Pharmacotherapy Effect of Adderall

Intervention

Drug:
• Adderall
Participants will be administered Adderall
• Placebo
Participants will be administered placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions	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.	A total of 4 imagining sessions, an average of 60 minutes each