E-cigarettes and Cardiovascular Function

NCT03061253 | Completed

• 1 other identifier: HWB-2016-17-S&E-10
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Cardiovascular Diseases; Microcirculation; Macrocirculation

Keywords

Electronic Cigarettes; Laser Doppler Flowmetry; Ultrasound; Nicotine Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD).

  Macro-vascular function assessment.

  6 months following quit day.

Secondary Outcomes (9)

• Intervention effect on Flow-mediated dilatation assessed via ultrasound (%FMD).

  3 days and 3 months following quit day.

• Intervention effect on Laser Doppler Flowmetry (Perfusion Units).

  3 days, 3 months and 6 months following quit day.

• Intervention effect on Mean Arterial Pressure.

  3 and 6 months following quit day.

• Intervention effect on Total Cholesterol/LDL ratio.

  3 and 6 months following quit day.

• Intervention effect on Cardiovascular disease risk-reduction (Q-Risk assessment score).

  3 and 6 months following quit day.

Other Outcomes (1)

• Physical activity assessment

  3 months and 6 months following quit day.

Study Arms (3)

Nicotine-inclusive e-cigarettes

EXPERIMENTAL

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

Other: Electronic Cigarette and behavioural change support.

Nicotine-free e-cigarettes

EXPERIMENTAL

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.

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

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.

Interventions

Electronic Cigarette and behavioural change support. OTHER

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.

Also known as: e-cigarette

Nicotine-inclusive e-cigarettes

Nicotine-Free Electronic Cigarette and behavioural change support. OTHER

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.

Also known as: Nicotine-free e-cigarette

Nicotine-free e-cigarettes

Nicotine Replacement Therapy and behavioural change support. OTHER

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.

Also known as: NRT

Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• King's College London: collaborator
• Heart Research U.K.: collaborator
• Help2Change: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Location

Related Publications (3)

• Klonizakis M, Gumber A, McIntosh E, Brose LS. Medium- and longer-term cardiovascular effects of e-cigarettes in adults making a stop-smoking attempt: a randomized controlled trial. BMC Med. 2022 Aug 16;20(1):276. doi: 10.1186/s12916-022-02451-9.

  PMID: 35971150 DERIVED

• Jones G, McIntosh E, Brose LS, Klonizakis M. Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette. J Addict Med. 2022 May-Jun 01;16(3):272-277. doi: 10.1097/ADM.0000000000000881.

  PMID: 34128486 DERIVED

• Klonizakis M, Crank H, Gumber A, Brose LS. 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. BMC Public Health. 2017 Apr 4;17(1):293. doi: 10.1186/s12889-017-4206-y.

  PMID: 28376818 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Cardiovascular Diseases; Vaping

Interventions

Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Study Officials

• Markos Klonizakis, DPhil

  Reader (Clinical Physiology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: April 24, 2017
• Primary Completion: April 21, 2020
• Study Completion: December 23, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

GB (1)