Sheffield Hallam University
Sheffield, Yorkshire, S10 2BP, United Kingdom
NCT Number: NCT03061253
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Sheffield, Yorkshire, S10 2BP, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study team will assess prospective participants and will not include in the study those who appear too frail or have health problems (e.g. dementia, Alzheimer's etc.) that might prevent them of giving a conscious, informed consent.
The nicotine strength of Group A (nicotine-inclusive e-cigarettes) cartridges will be 18 mg/ml of nicotine strength. All participants will receive up to 6 behavioural change support sessions over the 3-month intervention period.
Other names: e-cigarette
Group B participants will receive nicotine-free cartridges for the period of the intervention. All participants will receive up to 6 behavioural change support sessions over the 3-month intervention period.
Other names: Nicotine-free e-cigarette
Group C participants will be referred to smoking cessation services where they will be expected to receive Nicotine Replacement Therapy and up to 6 behavioural change support sessions over the 3-month intervention period, as per current guidelines.
Other names: NRT
Time frame: 6 months following quit day.
Macro-vascular function assessment.
Time frame: 3 days and 3 months following quit day.
Macro-vascular function assessment.
Time frame: 3 days, 3 months and 6 months following quit day.
Micro-vascular function assessment.
Time frame: 3 and 6 months following quit day.
Mean arterial pressure assessment.
Time frame: 3 and 6 months following quit day.
Finger prick test (Total Cholesterol/LDL).
Time frame: 3 and 6 months following quit day.
Q-risk assessment.
Time frame: 3 months following quit day.
Interview assessments of patient experiences.
Time frame: 6 months following quit day.
Health economic assessment of the intervention.
Time frame: 3 days, 3 months and 6 months following quit day.
Carbon Monoxide assessment
Time frame: 3 days, 3 months and 6 months following quit day.
Mean arterial pressure assessments
Time frame: 3 months and 6 months following quit day.
Short Form (SF)- International Physical Activity Questionnaire (IPAQ)
Sheffield Hallam University
Other
Impact on Cardiovascular Function in Smokers Making a Quit Attempt Using E-cigarettes Compared With Smokers Making a Quit Attempt With Prescription Nicotine-Replacement Therapy
Acronym: ISME-NRT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03612336
Behavior, Cardiovascular Diseases
Lausanne, Canton of Vaud, Switzerland
View Trial DetailsNCT03084822
Behavior, Body Weight
View Trial DetailsNCT04772144
Behavior, Cardiovascular Diseases
Drammen, Akershus, Norway
View Trial DetailsNCT05049174
Behavior, Cardiovascular Diseases
Drammen, Akershus, Norway
View Trial Details