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NCT02979327 Clinical Trial

Cardiovascular Effects of Adderall in Healthy Adults.

Hemodynamics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02979327
Other study ID # 16-004743
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 1, 2018
Est. completion date July 23, 2021

Study information
Verified date April 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 23, 2021
Est. primary completion date July 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Adderall capsule
Amphetamine
• Placebo capsule
Placebo capsule

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in blood pressure Baseline; 3 hours after intake of active drug/placebo drug
Primary Change in heart rate Baseline; 3 hours after intake of active drug/placebo drug
Secondary Change in plasma catecholamines Baseline; 3 hours after intake of active drug/placebo drug
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