The Effects of Nicotine Chewing Gum in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-01

Brief Summary

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The objective of this experiment is:

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

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Detailed Description

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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.

Conditions

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Low Blood Pressure Parkinsons Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicotine Gum

Nicotine chewing gum administered for 30 minutes

Group Type EXPERIMENTAL

Nicotine gum

Intervention Type DIETARY_SUPPLEMENT

Nicotine chewing gum

Interventions

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Nicotine gum

Nicotine chewing gum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No