| Study name |
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 |
| Methods |
Pragmatic, 3‐group, randomized, assessor‐blinded, single‐centre trial
Setting: Centre for Sport and Exercise Science (CSES) of Sheffield Hallam University, UK
Recruitment: From the community in the wider Sheffield area will be by: i) low‐cost newspaper and post‐office advertisement, ii) posters in local pharmacies, libraries, mosques, churches, and clubs, iii) social media or search engine advertisement (Facebook, Google ads) iv) notices in newsletters or participation in outreach events of community organizations (such as Sheffield U3A and AGE UK), iv) a study website, and v) out‐reach events in local ethnic community centres or places of worship |
| Participants |
Estimated enrolment: 258 participants (86 participants arm)
Inclusion Criteria:
Age > 18 years of either sex People who smoke (at least 10 cpd for the past year) Willing (by declaration) to attempt quit smoking by using the NHS services or e‐cigarettes
Exclusion Criteria:
Inability to walk Recent (within 6 months) cardiovascular disease event (e.g. stroke, myocardial infarction) or cardiac surgery Insulin‐controlled diabetes mellitus or with co‐existing skin conditions, leg ulcers, vasculitis or deep venous occlusion (as these may affect their cardiovascular function) Pregnancy Requiring major surgery during the course of the study) Contra‐indications/unsuitability for NRT Current daily use of e‐cigarettes Currently undertaking a cessation attempt supported by a smoking cessation clinic Unable to give informed consent
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| Interventions |
a) Complimentary e‐cigarette equipment and refills (Tornado V5, Joyetech, Shenzhen, China) at allocation stage, together with instructions on the correct usage of e‐cigarettes. They will also receive behavioral support for a 3‐month period. The nicotine strength of Group A cartridges will be up to 18 mg/ml nicotine strength b) As a), but with nicotine‐free liquid c) Referral to NHS smoking cessation clinics and will receive NRT in conjunction with behavioral support |
| Outcomes |
Follow‐up: Within 3 days of “quit date”, 3 and 6 months past quit date
Outcome measures:
Macro‐vascular function (FMD assessment) Micro‐vascular function Smoking status at 3 and 6 months, self‐reported and biochemically validated by exhaled air measurement of < 10 ppm CO Change in CVD risk using Q‐risk assessment Health Economic effects using EQ5D‐L Total cholesterol and High Density lipoprotein via fingerprick blood sample Participant experiences' assessment
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| Starting date |
24 April 2017 |
| Contact information |
Markos Klonizakis, m.klonizakis@shu.ac.uk |
| Notes |
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