ISME-NRT: E-cigarettes and Cardiovascular Function

Sponsor

Sheffield Hallam University (Other)

Overall Status

Completed

CT.gov ID

NCT03061253

Collaborator

King's College London (Other), Heart Research U.K. (Other), Help2Change (Other)

248

Enrollment

Location

Arms

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Cardiovascular Diseases Microcirculation Macrocirculation	Other: Electronic Cigarette and behavioural change support. Other: Nicotine-Free Electronic Cigarette and behavioural change support. Other: Nicotine Replacement Therapy and behavioural change support.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

248 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 24, 2017

Actual Primary Completion Date :

Apr 21, 2020

Actual Study Completion Date :

Dec 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nicotine-inclusive e-cigarettes Participants will receive e-cigarettes (nicotine-inclusive) combined with behavioural change support over a 3 month period.	Other: Electronic Cigarette and behavioural change support. 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
Experimental: Nicotine-free e-cigarettes Participants will receive e-cigarettes (nicotine-free) combined with behavioural change support over a 3 month period.	Other: Nicotine-Free Electronic Cigarette and behavioural change support. 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
Active Comparator: Nicotine Replacement Therapy (NRT) Participants will be referred to smoking cessation services where they will be expected to receive Nicotine Replacement Therapy combined with behavioural change support over a 3 month period.	Other: Nicotine Replacement Therapy and behavioural change support. 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

Arm

Intervention/Treatment

Experimental: Nicotine-inclusive e-cigarettes

Participants will receive e-cigarettes (nicotine-inclusive) combined with behavioural change support over a 3 month period.

Other: Electronic Cigarette and behavioural change support.

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

Experimental: Nicotine-free e-cigarettes

Participants will receive e-cigarettes (nicotine-free) combined with behavioural change support over a 3 month period.

Other: Nicotine-Free Electronic Cigarette and behavioural change support.

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

Active Comparator: Nicotine Replacement Therapy (NRT)

Participants will be referred to smoking cessation services where they will be expected to receive Nicotine Replacement Therapy combined with behavioural change support over a 3 month period.

Other: Nicotine Replacement Therapy and behavioural change support.

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

Outcome Measures

Primary Outcome Measures

Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). [6 months following quit day.]
Macro-vascular function assessment.

Secondary Outcome Measures

Intervention effect on Flow-mediated dilatation assessed via ultrasound (%FMD). [3 days and 3 months following quit day.]
Macro-vascular function assessment.
Intervention effect on Laser Doppler Flowmetry (Perfusion Units). [3 days, 3 months and 6 months following quit day.]
Micro-vascular function assessment.
Intervention effect on Mean Arterial Pressure. [3 and 6 months following quit day.]
Mean arterial pressure assessment.
Intervention effect on Total Cholesterol/LDL ratio. [3 and 6 months following quit day.]
Finger prick test (Total Cholesterol/LDL).
Intervention effect on Cardiovascular disease risk-reduction (Q-Risk assessment score). [3 and 6 months following quit day.]
Q-risk assessment.
Patient experiences' assessment (Interview). [3 months following quit day.]
Interview assessments of patient experiences.
Health Economics (Cost Utility Analysis). [6 months following quit day.]
Health economic assessment of the intervention.
Carbon Monoxide assessment [3 days, 3 months and 6 months following quit day.]
Carbon Monoxide assessment
Mean Arterial Pressure [3 days, 3 months and 6 months following quit day.]
Mean arterial pressure assessments

Other Outcome Measures

Physical activity assessment [3 months and 6 months following quit day.]
Short Form (SF)- International Physical Activity Questionnaire (IPAQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

smokers (at least 10 cigarettes/ day for the past year)
willing to attempt quit smoking by using the National Health Service smoking cessation services or via e-cigarette use.

Exclusion Criteria:

Non-ambulant people and people with a recent (e.g. within 6 months) cardiovascular disease event (e.g. stroke, myocardial infarction) or cardiac surgery,
people with insulin-controlled diabetes mellitus or with coexisting skin conditions, leg ulcers, vasculitis or deep venous occlusion (as these may affect their cardiovascular function),
pregnant women,
people who require major surgery (which will prevent them of taking part in the study)
people who following referral to the smoking cessation services, are advised that Nicotine Replacement Therapy is not appropriate for them,
people who are currently using e-cigarettes on a daily basis, or currently undertaking an attempt within a smoking cessation service,
people who are judged to be unable or are unwilling to give informed consent.

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.