Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

Conditions
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Expectancy Versus Pharmacotherapy Effect of Adderall

Intervention / Treatment
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* Drug: Adderall
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 X 2, within-subjects, balanced placebo design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adderall/Truth<br>Participants will be told they are receiving Adderall and will actually be administered Adderall. | Drug: Adderall<br>* Participants will be administered Adderall<br>|
| Placebo Comparator: Placebo/Truth<br>Participants will be told they are receiving placebo and will actually be administered placebo. | Drug: Placebo<br>* Participants will be administered placebo<br>|
| Experimental: Adderall/Deception<br>Participants will be told they are receiving Adderall and will actually be administered placebo. | Drug: Placebo<br>* Participants will be administered placebo<br>|
| Experimental: Placebo/Deception<br>Participants will be told they are receiving placebo and will actually be administered Adderall. | Drug: Adderall<br>* Participants will be administered Adderall<br>|

What is the study measuring?
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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 |