Cardiovascular System, Hemodynamics
Conditions
Brief summary
This study is designed to investigate the cardiovascular response (blood pressure, heart rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall in healthy adults.
Interventions
DRUGAdderall capsule
25 mg orally one time
DRUGPlacebo capsule
Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults 18 years of age and older 2. Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness 3. Subjects who are on no medications 4. Subjects with no prior history of regular amphetamine use, and non-prescription stimulants 5. Nonsmokers
Exclusion criteria
1. Subjects with known cardiovascular disease, thyroid disease 2. Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence 3. Subjects currently taking medications 4. Prior history of regular amphetamine use, or non-prescription stimulants 5. Smokers 6. Pregnant subjects 7. Known lactose intolerance (due to presence of lactose in the prepared medication) 8. Family history of sudden cardiac death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Baseline and 3 hours | Systolic blood pressure (top number of blood pressure reading) |
| Diastolic Blood Pressure | Baseline and 3 hours | Diastolic blood pressure (bottom number of blood pressure reading) |
| Mean Arterial Pressure (MAP) | Baseline and 3 hours | Mean arterial pressure (MAP) is a measure of the average blood pressure in the large arteries. It accounts for the blood flow and resistance. Measured in millimeters of mercury (mmHg) |
| Heart Rate | Baseline and 3 hours | Number of beats per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Norepinephrine | baseline and 3 hours | Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adderall First, Then Placebo Subjects received an Adderall capsule at the first study visit, then they received a Placebo capsule at the second study visit.
Adderall capsule: 25 mg orally one time
Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time. | 17 |
| Placebo First, Then Adderall Subjects received a Placebo capsule at the first study visit, then they received an Adderall capsule at the second study visit.
Adderall capsule: 25 mg orally one time
Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time. | 13 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo First, Then Adderall | Total | Adderall First, Then Placebo |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 5 | 26 years STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 13 participants | 30 participants | 17 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 1 / 29 | 2 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Diastolic Blood Pressure
Diastolic blood pressure (bottom number of blood pressure reading)
Time frame: Baseline and 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adderall | Diastolic Blood Pressure | baseline | 72 mmHg | Standard Error 2 |
| Adderall | Diastolic Blood Pressure | 3 hours | 78 mmHg | Standard Error 2 |
| Placebo | Diastolic Blood Pressure | 3 hours | 71 mmHg | Standard Error 2 |
| Placebo | Diastolic Blood Pressure | baseline | 72 mmHg | Standard Error 1 |
Primary
Heart Rate
Number of beats per minute
Time frame: Baseline and 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adderall | Heart Rate | baseline | 60 beats/min | Standard Error 2 |
| Adderall | Heart Rate | 3 hours | 70 beats/min | Standard Error 3 |
| Placebo | Heart Rate | baseline | 59 beats/min | Standard Error 2 |
| Placebo | Heart Rate | 3 hours | 61 beats/min | Standard Error 2 |
Primary
Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) is a measure of the average blood pressure in the large arteries. It accounts for the blood flow and resistance. Measured in millimeters of mercury (mmHg)
Time frame: Baseline and 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adderall | Mean Arterial Pressure (MAP) | baseline | 87 mmHg | Standard Error 2 |
| Adderall | Mean Arterial Pressure (MAP) | 3 hours | 94 mmHg | Standard Error 2 |
| Placebo | Mean Arterial Pressure (MAP) | baseline | 86 mmHg | Standard Error 1 |
| Placebo | Mean Arterial Pressure (MAP) | 3 hours | 86 mmHg | Standard Error 2 |
Primary
Systolic Blood Pressure
Systolic blood pressure (top number of blood pressure reading)
Time frame: Baseline and 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adderall | Systolic Blood Pressure | baseline | 116 mmHg | Standard Error 2 |
| Adderall | Systolic Blood Pressure | 3 hours | 126 mmHg | Standard Error 2 |
| Placebo | Systolic Blood Pressure | baseline | 116 mmHg | Standard Error 2 |
| Placebo | Systolic Blood Pressure | 3 hours | 115 mmHg | Standard Error 2 |
Secondary
Plasma Norepinephrine
Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL
Time frame: baseline and 3 hours
Population: Data was not collected nor analyzed for four subjects in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adderall | Plasma Norepinephrine | 3 hours | 301 pg/ml | Standard Error 14 |
| Adderall | Plasma Norepinephrine | baseline | 215 pg/ml | Standard Error 15 |
| Placebo | Plasma Norepinephrine | 3 hours | 227 pg/ml | Standard Error 17 |
| Placebo | Plasma Norepinephrine | baseline | 217 pg/ml | Standard Error 23 |