Low Blood PressurePDNCT02452125
The Effects of Nicotine Chewing Gum in Parkinson's Disease
A study testing Nicotine gum in people with Low Blood Pressure and Parkinsons Disease, run by New York Institute of Technology at 1 site in United States.
Trial summary
The objective of this experiment is: To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Blood Pressure, Parkinsons Disease
- What is being tested?
- Nicotine gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of PD
- a diastolic BP less than 90 mmHg
- and/or a systolic BP lower than 100mHg.
Who cannot join
- current tobacco users in all forms of tobacco
- severe dysphasia (difficulty swallowing)
- previous tobacco users who might be at risk for re-addiction.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11758
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Blood Pressure, Parkinsons Disease
- Being tested
- Nicotine gum
- Medical subject headings
- Hypotension, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine gumDietary supplement
Nicotine chewing gum
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Gum | Experimental | Nicotine chewing gum administered for 30 minutes Receives: Dietary Supplement: Nicotine gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: 90 minutes
Secondary outcomes (1)
Heart Rate
Measured: 90 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne DiFrancisco-Donoghue, New York Institute of Technology
- Investigators
- Joanne Donoghue, PhD, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452125
- Sponsor's protocol ID
- BHS-1118
- Acronym
- PD
- Status last verified
- Jul 2017
- First submitted
- 20 May 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02452125
- Acronym / sponsor ID
- PD / BHS-1118
- Conditions
- Low Blood Pressure, Parkinsons Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Gum | Experimental | Dietary Supplement: Nicotine gumNicotine chewing gum administered for 30 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of PD
- a diastolic BP less than 90 mmHg
- and/or a systolic BP lower than 100mHg.
Key exclusion criteria (3 listed)
- current tobacco users in all forms of tobacco
- severe dysphasia (difficulty swallowing)
- previous tobacco users who might be at risk for re-addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine gumNicotine chewing gum | Dietary supplement | Nicotine Gum |
Primary outcome
Blood Pressure
Time frame: 90 minutes
1 secondary outcome
Heart Rate
Time frame: 90 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Donoghue, PhD principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine gum in people with Low Blood Pressure and Parkinsons Disease, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.