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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
| University of Geneva, Switzerland | OTHER |
| University of Zurich | OTHER |
| State Hospital, St. Gallen |
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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 60-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 6,12, 24, 60 months, participants will be asked to come to a clinical visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants will received the Innokin Endura T20-S starter kit as intervention device. We use the e-liquids produced by the company Gaïatrend in France. Nicotine concentrations available will be 0 mg/ml, 6 mg/ml, 11 mg/ml and 19.6 mg/ml. Following aromas will be available to be chosen by the study participants: FR-4 (tobacco flavor) and FR-M (tobacco flavor), FRESH MINT (menthol flavor), RASPBERRY#2 (fruity flavor), RED FRUITS (fruity flavor) or GREEN APPLE (fruity flavor). The proportion of propylene glycol and vegetal glycerin will be 76/24 for all e-liquids. The components of the e-liquids will be propylene glycol, vegetal glycerin, medical-quality nicotine, alcohol and aromas. |
|
| Control group | Active Comparator | Participants in the control intervention will receive standard-of-care (SOC) in form of smoking cessation counseling (SCC) only. |
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| 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 60-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, 12, 24 and 60 months, participants will be asked to come to a clinical visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (1.1) | 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). | 12 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). | 24 months post quit date |
| Validated 7-day point prevalence abstinence (2.1) | 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). | 60 months post quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported 7-day point prevalence abstinence | Self-report of having smoked no cigarettes in the past seven days. | 12, 24 and 60 months post quit date |
| Continuous smoking abstinence | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reto Auer, Prof.Dr.med. | Berner Institut für Hausarztmedizin; Universität Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinique Médicale Universitaire, 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. |
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| OTHER_GOV |
| Swiss National Science Foundation | OTHER |
| Krebsforschung Schweiz, Bern, Switzerland | OTHER |
| Federal Office of Public Health, Switzerland | OTHER_GOV |
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Statisticians and laboratory personnel will be blinded to group allocation.
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| 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 60-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, 12, 24 and 60 months, participants will be asked to come to a clinical visit. |
|
| 12, 24 and 60 months post quit date |
| 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). | 12, 24 and 60 months post quit date |
| Self-reported smoking abstinence allowing a 2-week'grace period' | Smoking abstinence allowing a 2-week'grace period' after the target quit date. | 12, 24 and 60 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). | 12, 24 and 60 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). | 12, 24 and 60 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. | 12, 24 and 60 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). | 12, 24 and 60 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). | 12, 24 and 60 months post quit date |
| Number of cigarettes smoked per day (CPD) | self-reported | 12, 24 and 60 months post quit date |
| Change in number of cigarettes smoked per day (CPD) | self-reported.Successful reduction defined as 50% reduction in CPD. | 12, 24 and 60 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. | 12, 24 and 60 months post quit date |
| Withdrawal | The physical signs and symptoms associated with withdrawal, measured using the Minnesota Tobacco Withdrawal Scale. 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. | 12, 24 and 60 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. | 12, 24 and 60 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. | 12, 24 and 60 months post quit date |
| Use of any ENDS | self-reported on whether and how often they used any ENDS | 12, 24 and 60 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. | 12, 24 and 60 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. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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