NCT03061253: ISME-NRT

E-cigarettes and Cardiovascular Function

Completed NA Last updated 12 July 2021

What this trial tests

NA trial testing Electronic Cigarette and behavioural change support. in Smoking Cessation in 248 participants. Completed in 23 December 2020.

Timeline

24 April 2017

Primary endpoint
21 April 2020

23 December 2020

Quick facts

Lead sponsor	Sheffield Hallam University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	248
Start date	24 April 2017
Primary completion	21 April 2020
Estimated completion	23 December 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Electronic Cigarette and behavioural change support.
• Nicotine-Free Electronic Cigarette and behavioural change support.
• Nicotine Replacement Therapy and behavioural change support.

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Microcirculation — all drugs for Microcirculation →
• Macrocirculation — all drugs for Macrocirculation →

Sponsor

Sheffield Hallam University

Who can join

18 and older, any sex, with Smoking Cessation or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The large current uptake of e-cigarettes (2.8 million U.K. users in 2016; 26), the continuous involvement of e-cigarettes (which potentially affects their contents as well), the uncertainty about their medium- and longer-term effects, and the need to promote smoking cessation as means of reducing Cardiovascular disease, dictate that more research is urgently needed. Research exploring the impact of e-cigarettes on cardiovascular function/ health has been requested by the European Parliament, the British Medical Association, regulatory agencies, clinicians and researchers, as there is currently no consensus within the smoking cessation community as to the potential impact of e-cigarettes. With e-cigarettes being successful in replacing traditional cigarettes (i.e. up to 42% within a month), such studies should not only be efficacy-focused, but should also explore the physiological effects of e-cigarettes, as preliminary work in the field is contrasting and limited, in both the acute- and longer-term timeframe. Furthermore, as e-cigarettes are not simple nicotine-based products, the general public, researchers and government agencies cannot rely on the existing research exploring the effects of nicotine on the cardio-vasculature (e.g. coronary and peripheral vasoconstriction, intravascular inflammation and deregulation of cardiac autonomic function as well as inhibition of microcirculation). Thus, the lack of direct evidence - which would clarify the degree of safety of e-cigarettes for the user's vascular system and determine their longer-term cardiovascular disease risk - increases the need for research in the field.

Such studies will supply in-depth information to service-users and policy-makers, especially as the recently-initiated U.K.'s "Medicines and Healthcare Products Regulatory Agency" validation of e-cigarettes will increase likelihood of their introduction in smoking cessation clinics.

This study will bridge the existing knowledge gap and inform the general public, the scientific and the smoking cessation community in respect to the physiological (e.g. cardiovascular health) and participants' experience of both nicotine-inclusive and nicotine-free, e-cigarettes (when combined with behavioural change support) and compare it against a currently NHS-applied smoking cessation pathway that combines Nicotine Replacement Therapy and behavioural change support. This will allow future research to advance and optimize the pharmacological treatment of tobacco and nicotine dependence, by taking into consideration the study's physiological and Health Economics' findings.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Medium- and longer-term cardiovascular effects of e-cigarettes in adults making a stop-smoking attempt: a randomized controlled trial.
   Klonizakis M, Gumber A, McIntosh E, Brose LS. · · 2022 · cited 22× · PMID 35971150 · DOI 10.1186/s12916-022-02451-9
2. Smokers making a quit attempt using e-cigarettes with or without nicotine or prescription nicotine replacement therapy: Impact on cardiovascular function (ISME-NRT) - a study protocol.
   Klonizakis M, Crank H, Gumber A, Brose LS. · · 2017 · cited 19× · PMID 28376818 · DOI 10.1186/s12889-017-4206-y