HemodynamicsPhase 4NCT02979327

Cardiovascular Effects of Adderall in Healthy Adults.

A Phase 4 study testing Adderall capsule in people with Hemodynamics and Cardiovascular System, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hemodynamics, Cardiovascular System
What is being tested?: Adderall capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2018to 23 Jul 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults 18 years of age and older
Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness
Subjects who are on no medications
Subjects with no prior history of regular amphetamine use, and non-prescription stimulants
Nonsmokers

Who cannot join

Subjects with known cardiovascular disease, thyroid disease
Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence
Subjects currently taking medications
Prior history of regular amphetamine use, or non-prescription stimulants
Smokers
Pregnant subjects
Known lactose intolerance (due to presence of lactose in the prepared medication)
Family history of sudden cardiac death

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.

Conditions: Hemodynamics, Cardiovascular System
Being tested: Adderall capsule, Placebo capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adderall capsuleDrug
25 mg orally one time
Placebo capsuleDrug
Looks exactly like the study drug, but it contains no active ingredient. Taken one time.

Study groups in NCT02979327
Study group	Role	What they receive
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. Receives: Drug: Adderall capsule; Drug: Placebo capsule
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. Receives: Drug: Adderall capsule; Drug: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic Blood Pressure
Systolic blood pressure (top number of blood pressure reading)
Measured: Baseline and 3 hours
Diastolic Blood Pressure
Diastolic blood pressure (bottom number of blood pressure reading)
Measured: 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)
Measured: Baseline and 3 hours
Heart Rate
Number of beats per minute
Measured: Baseline and 3 hours

Secondary outcomes (1)

Plasma Norepinephrine
Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL
Measured: baseline and 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201823 Jul 2021

First posted1 Dec 2016 (estimated)
Study start1 Jun 2018
Primary completion23 Jul 2021
Study completion23 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemodynamicsStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02979327
Sponsor's protocol ID: 16-004743
Status last verified: Jan 2025
First submitted: 29 Nov 2016
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41770187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemodynamics trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.
ClinicalTrials.gov ID: NCT02979327
Acronym / sponsor ID: 16-004743
Conditions: Hemodynamics, Cardiovascular System
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Jun 2018 (actual)
Primary completion: 23 Jul 2021 (actual)
Study completion: 23 Jul 2021 (actual)
First posted: 1 Dec 2016 (estimated)
Results: Posted 14 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Adderall first, then Placebo	Experimental	Drug: Adderall capsule, Drug: Placebo capsuleParticipants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.
Placebo first, then Adderall	Experimental	Drug: Adderall capsule, Drug: Placebo capsuleParticipants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults 18 years of age and older
Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness
Subjects who are on no medications
Subjects with no prior history of regular amphetamine use, and non-prescription stimulants
Nonsmokers

Key exclusion criteria (8 listed)

Subjects with known cardiovascular disease, thyroid disease
Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence
Subjects currently taking medications
Prior history of regular amphetamine use, or non-prescription stimulants
Smokers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adderall capsule25 mg orally one time	Drug	Adderall first, then Placebo, Placebo first, then Adderall
Placebo capsuleLooks exactly like the study drug, but it contains no active ingredient. Taken one time.	Drug	Adderall first, then Placebo, Placebo first, then Adderall

Primary outcome

Systolic Blood Pressure
Time frame: Baseline and 3 hours
Systolic blood pressure (top number of blood pressure reading)
Diastolic Blood Pressure
Time frame: Baseline and 3 hours
Diastolic blood pressure (bottom number of blood pressure reading)
Mean Arterial Pressure (MAP)
Time frame: 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
Time frame: Baseline and 3 hours
Number of beats per minute

1 secondary outcome

Plasma Norepinephrine
Time frame: baseline and 3 hours

Results and safety

Results posted to the registry on 14 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adderall First, Then Placebo	17	16
Placebo First, Then Adderall	13	13

Primary outcome: Systolic Blood Pressure

Time frame: Baseline and 3 hours. Mean (Standard Error). Unit: mmHg

Measure	Adderall n = 29	Placebo n = 29
baseline	116 (2)	116 (2)
3 hours	126 (2)	115 (2)

Primary outcome: Diastolic Blood Pressure

Time frame: Baseline and 3 hours. Mean (Standard Error). Unit: mmHg

Measure	Adderall n = 29	Placebo n = 29
baseline	72 (2)	72 (1)
3 hours	78 (2)	71 (2)

Primary outcome: Mean Arterial Pressure (MAP)

Time frame: Baseline and 3 hours. Mean (Standard Error). Unit: mmHg

Measure	Adderall n = 29	Placebo n = 29
baseline	87 (2)	86 (1)
3 hours	94 (2)	86 (2)

Primary outcome: Heart Rate

Time frame: Baseline and 3 hours. Mean (Standard Error). Unit: beats/min

Measure	Adderall n = 29	Placebo n = 29
baseline	60 (2)	59 (2)
3 hours	70 (3)	61 (2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adderall	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Placebo	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41770187Somers 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.
Individual participant dataSharing planned: No

Related trials for Hemodynamics

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Svatikova, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adderall capsule in people with Hemodynamics and Cardiovascular System, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: Baseline and 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02979327, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.