The Effects of Nicotine Chewing Gum in Parkinson's Disease (PD)
Primary Purpose
Low Blood Pressure, Parkinsons Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine gum
Sponsored by
About this trial
This is an interventional treatment trial for Low Blood Pressure
Eligibility Criteria
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.
Sites / Locations
- New York Institute of Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nicotine Gum
Arm Description
Nicotine chewing gum administered for 30 minutes
Outcomes
Primary Outcome Measures
Blood Pressure
Secondary Outcome Measures
Heart Rate
Full Information
NCT ID
NCT02452125
First Posted
May 20, 2015
Last Updated
July 25, 2017
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02452125
Brief Title
The Effects of Nicotine Chewing Gum in Parkinson's Disease
Acronym
PD
Official Title
The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this experiment is:
To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.
Detailed 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 (Nicorette™). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Blood Pressure, Parkinsons Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine Gum
Arm Type
Experimental
Arm Description
Nicotine chewing gum administered for 30 minutes
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotine gum
Intervention Description
Nicotine chewing gum
Primary Outcome Measure Information:
Title
Blood Pressure
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Heart Rate
Time Frame
90 Minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Donoghue, PhD
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11758
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Nicotine Chewing Gum in Parkinson's Disease
We'll reach out to this number within 24 hrs