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
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular System
• Hemodynamics

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

External Links

•   Mayo Clinic Clinical Trials