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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adderall first, then Placebo | Experimental | Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit. |
|
| Placebo first, then Adderall | Experimental | Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adderall capsule | Drug | 25 mg orally one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading) | Baseline and 3 hours |
| Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading) | Baseline and 3 hours |
| 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) | Baseline and 3 hours |
| Heart Rate | Number of beats per minute | Baseline and 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Norepinephrine | Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL | baseline and 3 hours |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anna Svatikova, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41770187 | Derived | Somers KR, Bock JM, Covassin N, Bukartyk J, Rajendran A, Svatikova A. Acute Cardiovascular Responses to Amphetamine/Dextroamphetamine Salts (Adderall) in Adderall-Naive Young Adults: A Randomized Clinical Trial. Mayo Clin Proc. 2026 Mar 2:S0025-6196(25)18157-3. doi: 10.1016/j.mayocp.2025.12.005. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading) | Posted | Mean | Standard Error | mmHg | Baseline and 3 hours |
|
Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adderall | Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Svatikova, M.D., Ph.D. | Mayo Clinic | 507-284-3685 | Svatikova.Anna@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 | Nov 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C090411 | Adderall |
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| Placebo capsule | Drug | Looks exactly like the study drug, but it contains no active ingredient. Taken one time. |
|
| NOT COMPLETED |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
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| Primary | Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading) | Posted | Mean | Standard Error | mmHg | Baseline and 3 hours |
|
|
|
| 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) | Posted | Mean | Standard Error | mmHg | Baseline and 3 hours |
|
|
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| Primary | Heart Rate | Number of beats per minute | Posted | Mean | Standard Error | beats/min | Baseline and 3 hours |
|
|
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| Secondary | Plasma Norepinephrine | Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL | Data was not collected nor analyzed for four subjects in each arm | Posted | Mean | Standard Error | pg/ml | baseline and 3 hours |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Placebo | Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time. | 0 | 29 | 0 | 29 | 2 | 29 |
| Headache | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Tingling in fingers, toes, face | Nervous system disorders | Systematic Assessment |
|
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