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: Early Phase 1

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: No
• Genders Eligible for Study: All

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; Amphetamine; Drug: Placebo capsule; Placebo capsule
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; Amphetamine; Drug: Placebo capsule; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure	Baseline; 3 hours after intake of active drug/placebo drug
Change in heart rate	Baseline; 3 hours after intake of active drug/placebo drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plasma catecholamines	Baseline; 3 hours after intake of active drug/placebo drug

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 (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

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