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.

Study Overview

• Status: Completed
• Conditions: Expectancy Versus Pharmacotherapy Effect of Adderall
• Intervention / Treatment: Drug: Placebo; Drug: Adderall

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adderall/Truth; Participants will be told they are receiving Adderall and will actually be administered Adderall.	Drug: Adderall; Participants will be administered Adderall
Placebo Comparator: Placebo/Truth; Participants will be told they are receiving placebo and will actually be administered placebo.	Drug: Placebo; Participants will be administered placebo
Experimental: Adderall/Deception; Participants will be told they are receiving Adderall and will actually be administered placebo.	Drug: Placebo; Participants will be administered placebo
Experimental: Placebo/Deception; Participants will be told they are receiving placebo and will actually be administered Adderall.	Drug: Adderall; Participants will be administered Adderall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Karen Cropsey, Psy.D., University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Stimulants; Adderall
• Other Study ID Numbers: IRB-300000343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No