Expectancy Versus Pharmacotherapy Effect of Adderall
Conditions
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.
Interventions
DRUGAdderall
Participants will be administered Adderall
DRUGPlacebo
Participants will be administered placebo
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double-blind study. Research assistants will administer capsules, and based on package labeling, tell the participant if they are being administered Adderall or placebo. However, researchers and participants will be blind to which medication is actually being administered.
Intervention model description
2 X 2, within-subjects, balanced placebo design
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Only four subjects were recruited for this pilot study
Participants by arm
| Arm | Count |
|---|---|
| Adderall Within Subjects Design This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Adderall Within Subjects Design |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: A total of 4 imagining sessions, an average of 60 minutes each
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adderall/Truth | Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | 4 Participants |
| Placebo/Truth | Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | 4 Participants |
| Adderall/Deception | Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | 4 Participants |
| Placebo/Deception | Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | 4 Participants |