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OpenTrials
Completed

NCT Number: NCT02979327

Cardiovascular Effects of Adderall in Healthy Adults.

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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Key information

Conditions

Hemodynamics Cardiovascular System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Adderall capsule

Drug

25 mg orally one time

Placebo capsule

Drug

Looks exactly like the study drug, but it contains no active ingredient. Taken one time.

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline and 3 hours

    Systolic blood pressure (top number of blood pressure reading)

  2. Diastolic Blood Pressure

    Time frame: Baseline and 3 hours

    Diastolic blood pressure (bottom number of blood pressure reading)

  3. 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)

  4. Heart Rate

    Time frame: Baseline and 3 hours

    Number of beats per minute

Secondary outcomes

  1. Plasma Norepinephrine

    Time frame: baseline and 3 hours

    Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2016
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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