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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02452125
Other study ID # BHS-1118
Secondary ID
Status Completed
Phase N/A
First received May 20, 2015
Last updated July 25, 2017
Start date May 2015
Est. completion date June 1, 2017

Study information

Verified date July 2017
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this experiment is:

To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.


Description:

Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes.

After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicoretteā„¢). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- a diagnosis of PD

- a diastolic BP less than 90 mmHg

- and/or a systolic BP lower than 100mHg.

Exclusion Criteria:

- current tobacco users in all forms of tobacco

- severe dysphasia (difficulty swallowing)

- previous tobacco users who might be at risk for re-addiction.

Study Design


Intervention

Dietary Supplement:
Nicotine gum
Nicotine chewing gum

Locations

Country Name City State
United States New York Institute of Technology Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure 90 minutes
Secondary Heart Rate 90 Minutes
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