Smoking CessationISME-NRTNCT03061253
E-cigarettes and Cardiovascular Function
A study testing Electronic Cigarette and behavioural change support., Nicotine-Free Electronic Cigarette and behavioural change support. and Nicotine Replacement Therapy and behavioural change support. in people with Smoking Cessation and Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Cardiovascular Diseases, Microcirculation
- What is being tested?
- Electronic Cigarette and behavioural change support., Nicotine-Free Electronic Cigarette and behavioural change support. and Nicotine Replacement Therapy and behavioural change support.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, Yorkshire, S10 2BP
About this study
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
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.
- Being tested
- Electronic Cigarette and behavioural change support., Nicotine-Free Electronic Cigarette and behavioural change support., Nicotine Replacement Therapy and behavioural change support.
- Keywords
- Electronic Cigarettes, Laser Doppler Flowmetry, Ultrasound, Nicotine Replacement Therapy
- Medical subject headings
- Smoking Cessation, Cardiovascular Diseases, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Cigarette and behavioural change support.Other
Also called e-cigarette
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.
Nicotine-Free Electronic Cigarette and behavioural change support.Other
Also called Nicotine-free 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.
Nicotine Replacement Therapy and behavioural change support.Other
Also called NRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine-inclusive e-cigarettes | Experimental | Participants will receive e-cigarettes (nicotine-inclusive) combined with behavioural change support over a 3 month period. Receives: 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. Receives: 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. Receives: Other: Nicotine Replacement Therapy and behavioural change support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD).
Macro-vascular function assessment.
Measured: 6 months following quit day.
Secondary outcomes (9)
Intervention effect on Flow-mediated dilatation assessed via ultrasound (%FMD).
Macro-vascular function assessment.
Measured: 3 days and 3 months following quit day.
Intervention effect on Laser Doppler Flowmetry (Perfusion Units).
Micro-vascular function assessment.
Measured: 3 days, 3 months and 6 months following quit day.
Intervention effect on Mean Arterial Pressure.
Mean arterial pressure assessment.
Measured: 3 and 6 months following quit day.
Intervention effect on Total Cholesterol/LDL ratio.
Finger prick test (Total Cholesterol/LDL).
Measured: 3 and 6 months following quit day.
Intervention effect on Cardiovascular disease risk-reduction (Q-Risk assessment score).
Q-risk assessment.
Measured: 3 and 6 months following quit day.
Patient experiences' assessment (Interview).
Interview assessments of patient experiences.
Measured: 3 months following quit day.
Health Economics (Cost Utility Analysis).
Health economic assessment of the intervention.
Measured: 6 months following quit day.
Carbon Monoxide assessment
Carbon Monoxide assessment
Measured: 3 days, 3 months and 6 months following quit day.
Mean Arterial Pressure
Mean arterial pressure assessments
Measured: 3 days, 3 months and 6 months following quit day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start24 Apr 2017
- Primary completion21 Apr 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Heart Research U.K., Help2Change
- Responsible party
- Sponsor
- Investigators
- Markos Klonizakis, DPhil, Principal investigator, Reader (Clinical Physiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061253
- Sponsor's protocol ID
- HWB-2016-17-S&E-10
- Acronym
- ISME-NRT
- Status last verified
- Jul 2021
- First submitted
- 9 Feb 2017
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35971150Jones 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.
PubMed 34128486Klonizakis 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.
PubMed 28376818
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03061253
- Acronym / sponsor ID
- ISME-NRT / HWB-2016-17-S&E-10
- Keywords
- Electronic Cigarettes, Laser Doppler Flowmetry, Ultrasound, Nicotine Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- King's College London, Heart Research U.K., Help2Change
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine-inclusive e-cigarettes | Experimental | Other: Electronic Cigarette and behavioural change support.Participants will receive e-cigarettes (nicotine-inclusive) combined with behavioural change support over a 3 month period. |
| Nicotine-free e-cigarettes | Experimental | Other: Nicotine-Free Electronic Cigarette and behavioural change support.Participants will receive e-cigarettes (nicotine-free) combined with behavioural change support over a 3 month period. |
| Nicotine Replacement Therapy (NRT) | Active comparator | Other: Nicotine Replacement Therapy and behavioural change support.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Cigarette and behavioural change support.Also: e-cigaretteThe 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 | Nicotine-inclusive e-cigarettes |
| Nicotine-Free Electronic Cigarette and behavioural change support.Also: Nicotine-free e-cigaretteGroup 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 | Nicotine-free e-cigarettes |
| Nicotine Replacement Therapy and behavioural change support.Also: NRTGroup 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 | Nicotine Replacement Therapy (NRT) |
Primary outcome
Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD).
Time frame: 6 months following quit day.
Macro-vascular function assessment.
9 secondary outcomes
Intervention effect on Flow-mediated dilatation assessed via ultrasound (%FMD).
Time frame: 3 days and 3 months following quit day.
Intervention effect on Laser Doppler Flowmetry (Perfusion Units).
Time frame: 3 days, 3 months and 6 months following quit day.
Intervention effect on Mean Arterial Pressure.
Time frame: 3 and 6 months following quit day.
Intervention effect on Total Cholesterol/LDL ratio.
Time frame: 3 and 6 months following quit day.
Intervention effect on Cardiovascular disease risk-reduction (Q-Risk assessment score).
Time frame: 3 and 6 months following quit day.
Patient experiences' assessment (Interview).
Time frame: 3 months following quit day.
Health Economics (Cost Utility Analysis).
Time frame: 6 months following quit day.
Carbon Monoxide assessment
Time frame: 3 days, 3 months and 6 months following quit day.
Mean Arterial Pressure
Time frame: 3 days, 3 months and 6 months following quit day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Derived from this study: PubMed 35971150Klonizakis 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.
- Derived from this study: PubMed 34128486Jones 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.
- Derived from this study: PubMed 28376818Klonizakis 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.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markos Klonizakis, DPhil principal investigator
Reader (Clinical Physiology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cigarette and behavioural change support., Nicotine-Free Electronic Cigarette and behavioural change support. and Nicotine Replacement Therapy and behavioural change support. in people with Smoking Cessation and Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (time frame: 6 months following quit day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061253, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.