Trial Outcomes & Findings for Cardiovascular Effects of Adderall in Healthy Adults. (NCT NCT02979327)

NCT ID: NCT02979327

Last Updated: 2025-01-14

Results Overview

Systolic blood pressure (top number of blood pressure reading)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline and 3 hours
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	Adderall First, Then Placebo Subjects received an Adderall capsule at the first study visit, then they received a Placebo capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.	Placebo First, Then Adderall Subjects received a Placebo capsule at the first study visit, then they received an Adderall capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
First Intervention STARTED	17	13
First Intervention COMPLETED	16	13
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	16	13
Second Intervention COMPLETED	16	13
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Adderall First, Then Placebo Subjects received an Adderall capsule at the first study visit, then they received a Placebo capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.	Placebo First, Then Adderall Subjects received a Placebo capsule at the first study visit, then they received an Adderall capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
First Intervention Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Adderall First, Then Placebo n=17 Participants Subjects received an Adderall capsule at the first study visit, then they received a Placebo capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.	Placebo First, Then Adderall n=13 Participants Subjects received a Placebo capsule at the first study visit, then they received an Adderall capsule at the second study visit. Adderall capsule: 25 mg orally one time Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.	Total n=30 Participants Total of all reporting groups
Age, Continuous	26 years STANDARD_DEVIATION 5 • n=17 Participants	28 years STANDARD_DEVIATION 6 • n=13 Participants	27 years STANDARD_DEVIATION 5 • n=30 Participants
Sex: Female, Male Female	11 Participants n=17 Participants	5 Participants n=13 Participants	16 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=17 Participants	8 Participants n=13 Participants	14 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	13 participants n=13 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline and 3 hours

Systolic blood pressure (top number of blood pressure reading)

Outcome measures

Measure	Adderall n=29 Participants Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=29 Participants Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Systolic Blood Pressure baseline	116 mmHg Standard Error 2	116 mmHg Standard Error 2
Systolic Blood Pressure 3 hours	126 mmHg Standard Error 2	115 mmHg Standard Error 2

PRIMARY outcome

Timeframe: Baseline and 3 hours

Diastolic blood pressure (bottom number of blood pressure reading)

Outcome measures

Measure	Adderall n=29 Participants Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=29 Participants Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Diastolic Blood Pressure baseline	72 mmHg Standard Error 2	72 mmHg Standard Error 1
Diastolic Blood Pressure 3 hours	78 mmHg Standard Error 2	71 mmHg Standard Error 2

PRIMARY outcome

Timeframe: Baseline and 3 hours

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)

Outcome measures

Measure	Adderall n=29 Participants Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=29 Participants Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Mean Arterial Pressure (MAP) baseline	87 mmHg Standard Error 2	86 mmHg Standard Error 1
Mean Arterial Pressure (MAP) 3 hours	94 mmHg Standard Error 2	86 mmHg Standard Error 2

PRIMARY outcome

Timeframe: Baseline and 3 hours

Number of beats per minute

Outcome measures

Measure	Adderall n=29 Participants Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=29 Participants Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Heart Rate baseline	60 beats/min Standard Error 2	59 beats/min Standard Error 2
Heart Rate 3 hours	70 beats/min Standard Error 3	61 beats/min Standard Error 2

SECONDARY outcome

Timeframe: baseline and 3 hours

Population: Data was not collected nor analyzed for four subjects in each arm

Measurement of norepinephrine levels in the plasma. The normal range is 70 to 1700 pg/mL

Outcome measures

Measure	Adderall n=25 Participants Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=25 Participants Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
Plasma Norepinephrine baseline	215 pg/ml Standard Error 15	217 pg/ml Standard Error 23
Plasma Norepinephrine 3 hours	301 pg/ml Standard Error 14	227 pg/ml Standard Error 17

Adverse Events

Adderall

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adderall n=29 participants at risk Subjects who received an Adderall capsule at either the first or second study visit Adderall capsule: 25 mg orally one time	Placebo n=29 participants at risk Subjects who received a Placebo capsule at either the first or second study visit Placebo capsule: Looks exactly like the study drug, but it contains no active ingredient. Taken one time.
General disorders Lightheadedness	0.00% 0/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.	3.4% 1/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.
General disorders Headache	0.00% 0/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.	3.4% 1/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.
Psychiatric disorders Anxiety	3.4% 1/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.	0.00% 0/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.
Nervous system disorders Tingling in fingers, toes, face	0.00% 0/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.	0.00% 0/29 • Adverse events were collected on all subjects from baseline to end of study, approximately 2 months.

Additional Information

Anna Svatikova, M.D., Ph.D.

Mayo Clinic

Phone: 507-284-3685

Email: Svatikova.Anna@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place