NCT02452125

Brief Summary

The objective of this experiment is: To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

May 20, 2015

Last Update Submit

July 25, 2017

Conditions

Low Blood PressureParkinsons Disease

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    90 minutes

Secondary Outcomes (1)

  • Heart Rate

    90 Minutes

Study Arms (1)

Nicotine Gum

EXPERIMENTAL

Nicotine chewing gum administered for 30 minutes

Dietary Supplement: Nicotine gum

Interventions

Nicotine gumDIETARY_SUPPLEMENT

Nicotine chewing gum

Nicotine Gum

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of PD
  • a diastolic BP less than 90 mmHg
  • and/or a systolic BP lower than 100mHg.

You may not qualify if:

  • current tobacco users in all forms of tobacco
  • severe dysphasia (difficulty swallowing)
  • previous tobacco users who might be at risk for re-addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11758, United States

Location

MeSH Terms

Conditions

HypotensionParkinson Disease

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joanne Donoghue, PhD

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

US(1)