The Effects of Nicotine Chewing Gum in Parkinson's Disease (PD)

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

The objective of this experiment is:

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

Study Overview

• Status: Completed
• Conditions: Parkinsons Disease; Low Blood Pressure
• Intervention / Treatment: Dietary supplement: Nicotine gum

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11758
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotine Gum; Nicotine chewing gum administered for 30 minutes	Dietary supplement: Nicotine gum; Nicotine chewing gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure	90 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart Rate	90 Minutes

Collaborators and Investigators

• Sponsor: New York Institute of Technology

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: BHS-1118