Cardiovascular Effects of Adderall in Healthy Adults.

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular System; Hemodynamics
• Intervention / Treatment: Drug: Adderall capsule; Drug: Placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adderall first, then Placebo; Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.	Drug: Adderall capsule; 25 mg orally one time; Drug: Placebo capsule; Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Experimental: Placebo first, then Adderall; Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.	Drug: Adderall capsule; 25 mg orally one time; Drug: Placebo capsule; Looks exactly like the study drug, but it contains no active ingredient. Taken one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anna Svatikova, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 23, 2021
• Study Completion (Actual): July 23, 2021

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimated): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Stimulants; Adderall
• Other Study ID Numbers: 16-004743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No