A trial to assess the benefit of offering an e-cigarette starter kit to smokers attempting to stop smoking with varenicline
| ISRCTN | ISRCTN16931827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16931827 |
| Secondary identifying numbers | NTR-2018-180 |
- Submission date
- 30/07/2018
- Registration date
- 23/08/2018
- Last edited
- 08/07/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Varenicline is a medication used to help people quit smoking, as it helps to prevent nicotine addiction. E-cigarettes are electronic cigarettes, which are often used as an alternative to cigarettes to help people stop smoking. In English stop smoking services (SSS), the use of e-cigarettes along with varenicline has been associated with higher smoking abstinence rates than just using varenicline alone.
This study aims to look at the benefit of offering an e-cigarette starter kit to smokers attempting to quit smoking with varenicline, using carbon monoxide-verified abstinence 9-12 weeks after the quit date.
Who can participate?
Adult smokers interested in stopping smoking who attend SSS in London and opt for treatment with Varenicline and specialised one to one stop smoking support
What does the study involve?
Participants will be randomly allocated to either the intervention group or the control group. Participants in both groups will receive the usual care, which involves varenicline and behavioural support.
Participants in the intervention group will receive, in addition to usual care, a free e-cigarette starter kit. Those in the control group will receive the usual care only.
Over the 12 week period, participants in both groups will be asked to self-report their smoking abstinence and undergo carbon monoxide breath tests to validate this.
What are the possible benefits and risks of participating?
The possible benefit to participants is that taking part in this study may improve their chances of quitting smoking. The possible risk to participants taking part in this study is that e-cigarette use can lead to mouth and throat irritation, nausea and sleep disturbance.
Where is the study run?:
London local authority stop smoking services
When is the study starting and how long is it expected to run for?
July 2017 to July 2023
Who is funding the study?:
1. Global Research Awards for Nicotine Dependence (GRAND, supported by Pfizer) (USA)
2. Cancer Research UK (UK)
Who is the main contact?
Dr Lion Shahab, Senior Lecturer (Department of Behavioural Science and Health)
lion.shahab@ucl.ac.uk
Contact information
Scientific
1-19 Torrington Place
University College London
London
WC1E 7BH
United Kingdom
 ORCID ID |
0000-0003-4033-442X |
|---|---|
| Phone | +442076791895 |
| lion.shahab@ucl.ac.uk |
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a randomised controlled trial |
| Study acronym | E-ASSIST |
| Study objectives | Even with the most effective current pharmacotherapy, varenicline, the majority of quit attempts will fail. Observational data from the English stop smoking services (SSS) suggest adding e-cigarettes to varenicline and behavioural support could improve quit success rates in clinical practice. However, there is no randomised trial evidence. This study will assess the efficacy for smoking cessation of offering an e-cigarette starter kit compared with usual care for smokers attempting to stop smoking with varenicline and behavioural support. |
| Ethics approval(s) | University College London Research Ethics Committee, 22/06/2018, 8323/003 |
| Health condition(s) or problem(s) studied | Tobacco smoking cessation |
| Intervention | Current interventions as of 24/01/2019: Participants will be computer-randomised in a 1:1 ratio into either the intervention of the control group. This study will be limited to Stop Smoking Services (SSS) within London Local Authorities (LAs) and Cambridgeshire County Council that provide a standard 12 week treatment; therefore, participants will be block-randomised in LAs to ensure an equal distribution of control and intervention participants across services. Participants in the intervention group will receive the usual care of behavioural support and varenicline, along with an e-cigarette starter kit (compliant with EU regulation) and an information leaflet about e-cigarettes at the end of their pre-quit visit. The starter kit will contain a third generation e-cigarette and e-liquid (choice of nicotine concentration of 6 mg/ml, 12 mg/ml or 18 mg/ml) in tobacco flavour; a lower nicotine concentration will be offered if the initial concentration is perceived to be aversive) which will last for four weeks. Participants will be given brief in-person advice about how to use e-cigarettes, asked to try the e-cigarette during the session and encouraged to start using e-cigarettes from their target quit-date onwards and to seek out local vape shops to obtain further e-liquid, suited to their individual needs and flavour preference. After this pre-quit visit, participants will receive the same treatment as per standard SSS practice. Participants in the control group will receive usual care alone (behavioural support and varenicline). After the pre-quit treatment episode, participants in both conditions will receive the same treatment as per standard SSS practice and use of e-cigarettes (as well as varenicline) will be recorded at subsequent visits until the final follow-up, twelve weeks after the target quit date. It is anticipated that the study will take 30 months to allow for sufficient time to gain ethical approval and develop intervention material (4 months), to recruit and follow-up participants (24 months) and to transfer data from SSS to the study team (2 months). Previous interventions: Participants will be computer-randomised in a 1:1 ratio into either the intervention of the control group. This study will be limited to Stop Smoking Services (SSS) within London Local Authorities (LAs) that provide a standard 12 week treatment; therefore, participants will be block-randomised in LAs to ensure an equal distribution of control and intervention participants across services. Participants in the intervention group will receive the usual care of behavioural support and varenicline, along with an e-cigarette starter kit (compliant with EU regulation) and an information leaflet about e-cigarettes at the end of their pre-quit visit. The starter kit will contain a third generation e-cigarette and e-liquid (nicotine concentration 18 mg/ml in tobacco flavour; a lower nicotine concentration will be offered if the initial concentration is perceived to be aversive) which will last for four weeks. Participants will be given brief in-person advice about how to use e-cigarettes, asked to try the e-cigarette during the session and encouraged to start using e-cigarettes from their target quit-date onwards and to seek out local vape shops to obtain further e-liquid, suited to their individual needs and flavour preference. After this pre-quit visit, participants will receive the same treatment as per standard SSS practice. Participants in the control group will receive usual care alone (behavioural support and varenicline). After the pre-quit treatment episode, participants in both conditions will receive the same treatment as per standard SSS practice and use of e-cigarettes (as well as varenicline) will be recorded at subsequent visits until the final follow-up, twelve weeks after the target quit date. It is anticipated that the study will take 30 months to allow for sufficient time to gain ethical approval and develop intervention material (4 months), to recruit and follow-up participants (24 months) and to transfer data from SSS to the study team (2 months). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Smoking abstinence, self-reported between weeks 9-12 from the target quit date and validated by an expired air CO concentration of below 10 ppm at week 12 |
| Secondary outcome measures | Current secondary outcomes as of 24/01/2019: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation 6. For participants that have been in the trial for 6 months, CO –validated smoking abstinence at 6 months following the target quit-date will be measured Previous secondary outcomes: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation |
| Overall study start date | 01/07/2017 |
| Completion date | 01/07/2023 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1266 |
| Total final enrolment | 92 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Smoker 3. Attending SSS one-to-one specialist support in London LAs 4. Proficient in English 5. Firm target quit date 6. Elect to use varenicline to support quit attempt 7. Willing to try e-cigarettes |
| Key exclusion criteria | 1. Pregnant 2. Breastfeeding |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 21/12/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
E17 4JF
United Kingdom
5 George Street
Huntingdon
PE29 3AD
United Kingdom
8 Mint Walk
Croydon
London
CR0 1EA
United Kingdom
Lewisham High St
London
SE13 6LH
United Kingdom
Bexleyheath
London
DA6 7AT
United Kingdom
London
EN1 3XA
United Kingdom
Sponsor information
University/education
Gower St, Bloomsbury
London
WC1E 6BT
England
United Kingdom
| Website | http://www.ucl.ac.uk/iehc/research/behavioural-science-health |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | Protocol (not peer reviewed) | 05/06/2019 | 03/09/2020 | No | No |
| Results article | 23/06/2022 | 08/07/2022 | Yes | No |
Editorial Notes
08/07/2022: The reasons for early termination were that a key component of the trial design (the medication varenicline) was recalled by the manufacturer (Pfizer) due to safety concerns in summer 2021 and has not returned since. Publication reference and total final enrolment added.
02/02/2022: Recruitment to this study has been paused due to shortages in the medication (varenicline) used in both the intervention and control arms.
15/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2021 to 21/12/2022.
2. The overall trial end date was changed from 01/05/2022 to 01/07/2023.
3. The intention to publish date was changed from 01/05/2023 to 01/11/2023.
03/09/2020: Link to protocol (not peer-reviewed) added to the publications list.
12/06/2020: The scientific contact details have been made publicly visible.
07/05/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2020 to 01/06/2021.
2. The overall end date was changed from 01/03/2021 to 01/05/2022.
3. The intention to publish date was changed from 01/03/2022 to 01/05/2023.
4. The plain English summary was updated to reflect these changes.
24/01/2018: The following changes have been made to the trial record:
1. The study intervention has been changed
2. The secondary outcome measures have been changed
3. Cambridgeshire County Council, CAMQUIT Stop Smoking Service was added as a trial participating centre
4. London Borough of Croydon Stop Smoking Service was added as a trial participating centre
5. London Borough of Lewisham Stop Smoking Service was added as a trial participating centre
6. London Borough of Bexley Stop Smoking Service was added as a trial participating centre
7. London Borough of Enfield Stop Smoking Service was added as a trial participating centre
