Status:
COMPLETED
The Cardiovascular Impacts of Electronic Cigarettes in Comparison to the Use of Nicotine Replacement Patches
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Smoking, Tobacco
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ann...
Detailed Description
Tobacco smoking (TS) remains a major health challenge for people in Scotland. EC are presently the most popular nicotine replacement product used in England. Recently NHS Greater Glasgow and Clyde (NH...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03358953
Start Date
December 17 2016
End Date
July 13 2018
Last Update
September 18 2018
Active Locations (1)
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1
Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom, G51 4TF