The Effects of Nicotine Chewing Gum in Parkinson's Disease

Parkinsons Disease Clinical Trial

— PD  

Official title:

The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452125
• Other study ID #: BHS-1118
• 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
• 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 (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.

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.

Related Conditions & MeSH terms

• Hypotension
• Low Blood Pressure
• Parkinson Disease
• Parkinsons Disease

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