Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Expectancy Versus Pharmacotherapy Effect of Adderall

Treatments: Drug: Placebo; Drug: Adderall

Study type: Interventional

Funder types: Other

Identifiers

NCT03530631

IRB-300000343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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4 participants in 4 patient groups, including a placebo group

Adderall/Truth

Experimental group

Description:

Participants will be told they are receiving Adderall and will actually be administered Adderall.

Treatment:

Drug: Adderall

Placebo/Truth

Placebo Comparator group

Description:

Participants will be told they are receiving placebo and will actually be administered placebo.

Treatment:

Drug: Placebo

Adderall/Deception

Experimental group

Description:

Participants will be told they are receiving Adderall and will actually be administered placebo.

Treatment:

Drug: Placebo

Placebo/Deception

Experimental group

Description:

Participants will be told they are receiving placebo and will actually be administered Adderall.

Treatment:

Drug: Adderall