The Cardiovascular Impacts of Electronic Cigarettes in Comparison to the Use of Nicotine Replacement Patches

NCT03358953 | Completed

• 1 other identifier: GN16CH051
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300 million per annum. To minimise the clinical and financial burden of tobacco on national healthcare systems, Scotland's tobacco control strategy aims to create a "tobacco-free" generation by 2034, with the prevalence of smoking in the adult population reduced to ≤5 %. The multifaceted approach focuses upon tobacco prevention, protection and cessation. In relation to smoking cessation, the use of EC has exponentially increased since 2011, and EC are presently the most popular nicotine replacement product used in England. The Public Health England (PHE) Report published in August 2015 advocates the use of EC when other smoking cessation aids have failed.

Conditions

Smoking, Tobacco

Keywords

electronic cigarettes; cardiovascular; nicotine replacement patches

Outcome Measures

Primary Outcomes (1)

• Change in endothelial function as assessed by flow mediated dilation

  Change in endothelial function as assessed by flow mediated dilation

  12 weeks

Secondary Outcomes (5)

• Changes in respiratory function assessed through pulmonary function tests

  12 weeks

• Changes in endothelial function assessed by Endo-PAT2000, a non-invasive technique

  12 weeks

• • Changes in cardiovascular parameters through non-invasive haemodynamic measurements

  12 weeks

• • Changes in cardiovascular risk factor profile as assess through biomarkers markers of inflammation

  12 weeks

• • Changes in endothelial micoparticles

  12 weeks

Study Arms (2)

Electronic Cigarettes

OTHER

Participants wishing to quit tobacco smoking have an equal chance of being assigned to the electronic cigarette arm. They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services.

Device: Electron Cigarette

Nicotine replacement patches

OTHER

Participants wishing to quit tobacco smoking have an equal chance of being assigned to the nicotine replacement patch arm (standard care). They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services.

Device: Nicotine Replacement Patch

Interventions

Electron Cigarette DEVICE

Blended Tobacco flavour, 18mg/ml

Also known as: Smokemax Power e-cigarette

Electronic Cigarettes

Nicotine Replacement Patch DEVICE

NiQuitin 21mg

Also known as: NiQuitin

Nicotine replacement patches

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-65 years and wish to stop smoking. Smoker of at least 1-15 tobacco cigarette (TC) per day for ≥ six months Committed to attending weekly support sessions with NHSGGC Smokefree Services Must be willing to stop smoking tobacco cigarettes with the use of either nicotine replacement patches or an electronic cigarette with nicotine containing e-liquid.

You may not qualify if:

• Breastfeeding or pregnancy Use of EC or NRP within the past three months Uncontrolled hypertension - Blood pressure ≥165/95 mmHg
• Established history of cardiovascular defined as:
• Unstable angina, heart failure New York Heart Association (NYHA) Functional Classification classes III - IV Recent stroke, myocardial infarction, coronary artery bypass graft or percutaneous coronary angiogram within the last 3 months.
• Established renal disease defined as eGFR \<45 Established history of peripheral vascular disease Established history of Chronic Obstructive Pulmonary Disease. Illicit drug use Severe concurrent medical condition that would prevent participation in study procedures or malignant neoplasm or with life expectancy ≤ 3 months.
• Major depressive illness or other psychiatric conditions. Participants who decline participation in the study or who are unable to provide informed consent
• History of allergies to active substances, excipients or delivery device (patch) in NRP or EC
• NRP: See current Summary of Product Characteristics
• EC: Nicotine, Propylene Glycol (PG), Glycerol and water.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Glasgow Clinical Research Facility

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Tobacco Smoking; Vaping

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christian Delles, MBChB PhD

  Glasgow University and NHS GGC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: E-cigarette versus nicotine replacement patches

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: December 17, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 13, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

GB (1)