Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Phase 4

Completed

• Conditions: Expectancy Versus Pharmacotherapy Effect of Adderall
• Interventions: Drug: Placebo; Drug: Adderall

• Registration Number: NCT03530631
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Study Start: 2018-11-10
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Results First Submitted: 2019-07-29
• Results First Submitted QC: 2019-09-23
• Results First Posted: 2019-10-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Adderall/Deception	Placebo	Participants will be told they are receiving Adderall and will actually be administered placebo.
Placebo/Truth	Placebo	Participants will be told they are receiving placebo and will actually be administered placebo.
Placebo/Deception	Adderall	Participants will be told they are receiving placebo and will actually be administered Adderall.
Adderall/Truth	Adderall	Participants will be told they are receiving Adderall and will actually be administered Adderall.

Primary Outcome Measures

Name	Time	Method
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States