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OpenTrials
Completed

NCT Number: NCT02452125

The Effects of Nicotine Chewing Gum 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.

Completed

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Key information

Conditions

Low Blood Pressure Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Parkinsons Disease Synucleinopathies Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Institute of Technology

Old Westbury, New York, 11758, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine gum

Dietary Supplement

Nicotine chewing gum

Primary outcomes

  1. Blood Pressure

    Time frame: 90 minutes

Secondary outcomes

  1. Heart Rate

    Time frame: 90 Minutes

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

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

Acronym: PD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 22, 2015
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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