The Effects of Nicotine Chewing Gum in Parkinson's Disease

Not Applicable

Completed

• Conditions: Low Blood Pressure; Parkinsons Disease
• Interventions: Dietary Supplement: Nicotine gum

• Registration Number: NCT02452125
• Lead Sponsor: New York Institute of Technology

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine Gum	Nicotine gum	Nicotine chewing gum administered for 30 minutes

Primary Outcome Measures

Name	Time	Method
Blood Pressure	90 minutes

Secondary Outcome Measures

Name	Time	Method
Heart Rate	90 Minutes

Trial Locations

Locations (1)

New York Institute of Technology; 🇺🇸 Old Westbury, New York, United States