Cardiovascular Effects of Adderall in Healthy Adults.

NCT ID: NCT02979327

Last Updated: 2025-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-07-23

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodynamics Cardiovascular System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adderall first, then Placebo

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

Group Type EXPERIMENTAL

Adderall capsule

Intervention Type DRUG

25 mg orally one time

Placebo capsule

Intervention Type DRUG

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

Placebo first, then Adderall

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

Group Type EXPERIMENTAL

Adderall capsule

Intervention Type DRUG

25 mg orally one time

Placebo capsule

Intervention Type DRUG

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

Interventions

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Adderall capsule

25 mg orally one time

Intervention Type DRUG

Placebo capsule

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Anna Svatikova

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Svatikova, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-004743

Identifier Type: -

Identifier Source: org_study_id

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