Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Lausanne | OTHER |
| University of Geneva, Switzerland | OTHER |
| University of Zurich | OTHER |
| State Hospital, St. Gallen |
Not provided
Not provided
Not provided
Not provided
Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Only two rigorous randomized controlled trials (RCTs) on the efficacy of ENDS to help smokers quit have been published so far. They have promising, yet inconclusive results, as the number of included participants were small. The safety and potential adverse effects of ENDS are also largely unknown. While the aerosol the users inhale appears safe in laboratory conditions, the difference in exposure to chemicals (such as reduction in exposure to volatile organic compounds) and effects of chemicals on the body (adverse events, improved health-related outcomes and measures of oxidative stress) between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in an RCT.
This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals.
The primary hypothesis of this trial is that providing cigarette smokers willing to quit smoking tobacco cigarettes with ENDS leads to a higher rate of smokers who quit cigarette smoking than only smoking cessation counseling with nicotine replacement therapy (NRT), which represents nowadays the standard of care.
For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. Participants in both groups will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDS (vaporizer/e-cig) and smoking cessation counseling | Other | Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous smoking abstinence (1) | Self-report of having smoked no cigarettes from quit date, validated by urinary levels of anabasine. If anabasine is missing, validation by exhaled carbon monoxide (CO). | 6 months post quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous smoking abstinence (2) | Self-report of having smoked no cigarettes from quit date, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO). | 6 months post quit date |
| Self-reported smoking abstinence allowing a 2-week'grace period' |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reto Auer, Prof.Dr.med | Berner Institut für Hausarztmedizin; Universität Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24029165 | Background | Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9. | |
| 23826093 | Background | Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013. |
Not provided
Not provided
Not provided
| OTHER_GOV |
| Swiss National Science Foundation | OTHER |
Not provided
Not provided
Not provided
Statisticians and laboratory personnel will be blinded to group allocation.
Not provided
|
| Smoking cessation counseling | Other | Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit. |
|
Smoking abstinence allowing a 2-week'grace period' after the target quit date. |
| 4, 8 weeks and 6 months post quit date |
| Validated smoking abstinence allowing a 2-week'grace period' (1) | Smoking abstinence allowing a 2-week'grace period' after the target quit date, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO). | 6 months post quit date |
| Validated smoking abstinence allowing a 2-week'grace period' (2) | Smoking abstinence allowing a 2-week'grace period' after the target quit date, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO). | 6 months post quit date |
| Self-reported smoking abstinence allowing up to 5 cigarettes | Smoking abstinence allowing up to 5 cigarettes in total after the target quit date. | 1, 2, 4, 8 weeks and 6 months post quit date |
| Validated smoking abstinence allowing up to 5 cigarettes (1) | Smoking abstinence allowing up to 5 cigarettes in total after the target quit date, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO). | 6 months post quit date |
| Validated smoking abstinence allowing up to 5 cigarettes (2) | Smoking abstinence allowing up to 5 cigarettes in total after the target quit date, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO). | 6 months post quit date |
| Self-reported 7-day point prevalence abstinence | Self-report of having smoked no cigarettes in the past seven days. | 1, 2, 4, 8 weeks and 6 months post quit date |
| Validated 7-day point prevalence abstinence (1) | Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO). | 6 months post quit date |
| Validated 7-day point prevalence abstinence (2) | Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO). | 6 months post quit date |
| Number of cigarettes smoked per day (CPD) | self-reported | baseline, target quit date, 1, 2, 4, 8 weeks and 6 months post quit date |
| Change in number of cigarettes smoked per day (CPD) | self-reported. Successful reduction defined as 50% reduction in CPD. | baseline, 6 months post quit date |
| Use of any other smoking cessation products (NRT, Nicotine replacement therapy) | self-reported on whether and how often they used any NRT. | 1, 2, 4, 8 weeks and 6 months post quit date |
| Withdrawal | The physical signs and symptoms associated with withdrawal, measured using the Minnesota Tobacco Withdrawal Scale (http://www.med.uvm.edu/behaviorandhealth/minnwsdefault). The Minnesota Tobacco Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60. | baseline and 6 months post quit date |
| Nicotine dependence | Nicotine dependence measured using the Fagerström Test. The Fagerström Test for Nicotine Dependence (FTND, Heatherton TF et al., 1991) is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. Two items have four possible responses (0-3) and four items have two possible responses (0-1). The nicotine dependence score ranges from 0 to 10. A score between 0 and 2 is considered as a low nicotine dependence, a score between 3 to 5 is considered as a medium nicotine dependence, a score between 6 and 7 is considered as a high nicotine dependence and a score between 8 and 10 is considered as a very high nicotine dependence. | baseline and 6 months post quit date |
| Health-related quality of life | Measured using the Swiss EQ-5D. The EQ-5D questionnaire is a standardized measure of health status developed by the EuroQol Group (https://euroqol.org/). EQ-5D questionnaires have five dimensions: "Mobility", "Self-care," "Usual Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by five problem levels corresponding to participant response choices. | baseline and 6 months post quit date |
| Use of any ENDS | self-reported on whether and how often they used any ENDS | 1, 2, 4, 8 weeks and 6 months post quit date |
| Report on most common adverse events using ENDS | Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of ENDS, whether or not it is considered related to the product. | 1, 2, 4, 8 weeks and 6 months post quit date |
| University Clinic for General Internal Medicine, Bern University Hospital | Bern | 3010 | Switzerland |
| Département de médecine interne, Hôpitaux universitaires de Genève | Geneva | 1211 | Switzerland |
| Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich | Zurich | Switzerland |
| 27622384 | Background | Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, Stead LF, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2016 Sep 14;9(9):CD010216. doi: 10.1002/14651858.CD010216.pub3. |
| 27113014 | Background | Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, Andrews J, Zawertailo L, Ferrence R. Electronic Cigarettes for Smoking Cessation: A Systematic Review. Nicotine Tob Res. 2016 Oct;18(10):1926-1936. doi: 10.1093/ntr/ntw119. Epub 2016 Apr 25. |
| 25083263 | Background | Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430. |
| 1932883 | Background | Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. |
| 38354139 | Derived | Auer R, Schoeni A, Humair JP, Jacot-Sadowski I, Berlin I, Stuber MJ, Haller ML, Tango RC, Frei A, Strassmann A, Bruggmann P, Baty F, Brutsche M, Tal K, Baggio S, Jakob J, Sambiagio N, Hopf NB, Feller M, Rodondi N, Berthet A. Electronic Nicotine-Delivery Systems for Smoking Cessation. N Engl J Med. 2024 Feb 15;390(7):601-610. doi: 10.1056/NEJMoa2308815. |
| 35380498 | Derived | Nyilas S, Bauman G, Korten I, Pusterla O, Singer F, Ith M, Groen C, Schoeni A, Heverhagen JT, Christe A, Rodondi N, Bieri O, Geiser T, Auer R, Funke-Chambour M, Ebner L. MRI Shows Lung Perfusion Changes after Vaping and Smoking. Radiology. 2022 Jul;304(1):195-204. doi: 10.1148/radiol.211327. Epub 2022 Apr 5. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided