Cardiovascular Effects of Adderall in Healthy Adults.

NCT02979327 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-004743
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodynamics; Cardiovascular System

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Plasma Norepinephrine

  baseline and 3 hours

Study Arms (2)

Adderall first, then Placebo

EXPERIMENTAL

Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.

Drug: Adderall capsule; Drug: Placebo capsule

Placebo first, then Adderall

EXPERIMENTAL

Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.

Drug: Adderall capsule; Drug: Placebo capsule

Interventions

Adderall capsule DRUG

25 mg orally one time

Adderall first, then Placebo; Placebo first, then Adderall

Placebo capsule DRUG

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

Adderall first, then Placebo; Placebo first, then Adderall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Adderall

Results Point of Contact

• Title: Anna Svatikova, M.D., Ph.D.
• Organization: Mayo Clinic

Svatikova.Anna@mayo.edu

507-284-3685

Study Officials

• Anna Svatikova, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 1, 2016
• Study Start: June 1, 2018
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)