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
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Depression outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Smoking and depression are strongly associated. Individuals with depression are twice as likely to be smokers than persons without a depression. Studies have shown that attempts to quit tobacco smoking are more likely to fail for individuals with depression than without. Depressive symptoms are common in prolonged nicotine withdrawal and individuals with depression are more nicotine dependent and more likely to suffer depressive symptoms during nicotine withdrawal compared to smokers in the general population.
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. ENDS with nicotine containing e-liquids may be effective in assisting with tobacco smoking cessation without suffering depressive symptoms.
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 such as depression and exposure to inhaled chemicals.
For the main ESTxENDS trial (NCT03589989), 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. All participants will be followed over a 24-month period. Presence and severity of depression will be assessed using the 9-question depression scale from the patient health questionnaire (PHQ-9) at baseline and at 6, 12 and 24 months' follow-up.
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 24-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 and 24 months, participants will be asked to come to a clinical visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of severity of self-reported symptoms of depression_1 | Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). | 6 months post quit date |
| Assessment of severity of self-reported symptoms of depression_2 | Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). | 12 months post quit date |
| Assessment of severity of self-reported symptoms of depression_3 | Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). | 24 months post quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of change of severity of self-reported symptoms of depression | Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). | Change from baseline to 6,12, 24 months post quit date |
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 (BIHAM) | 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 |
|---|---|---|---|
| 19392908 | Background | Hall SM, Humfleet GL, Munoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. doi: 10.1111/j.1360-0443.2009.02548.x. Epub 2009 Apr 9. | |
| 16019961 | Background | Kalman D, Morissette SB, George TP. Co-morbidity of smoking in patients with psychiatric and substance use disorders. Am J Addict. 2005 Mar-Apr;14(2):106-23. doi: 10.1080/10550490590924728. |
Not provided
Not provided
Not provided
| OTHER_GOV |
| Swiss National Science Foundation | OTHER |
| Krebsforschung Schweiz, Bern, Switzerland | OTHER |
| Federal Office of Public Health, Switzerland | OTHER_GOV |
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 24-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 and 24 months, participants will be asked to come to a clinical visit. |
|
| 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 |
| 11086367 | Background | Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. doi: 10.1001/jama.284.20.2606. |
| 19023823 | Background | Ziedonis D, Hitsman B, Beckham JC, Zvolensky M, Adler LE, Audrain-McGovern J, Breslau N, Brown RA, George TP, Williams J, Calhoun PS, Riley WT. Tobacco use and cessation in psychiatric disorders: National Institute of Mental Health report. Nicotine Tob Res. 2008 Dec;10(12):1691-715. doi: 10.1080/14622200802443569. |
| 8465868 | Background | Glassman AH. Cigarette smoking: implications for psychiatric illness. Am J Psychiatry. 1993 Apr;150(4):546-53. doi: 10.1176/ajp.150.4.546. |
| 22429388 | Background | Weinberger AH, Pilver CE, Desai RA, Mazure CM, McKee SA. The relationship of major depressive disorder and gender to changes in smoking for current and former smokers: longitudinal evaluation in the US population. Addiction. 2012 Oct;107(10):1847-56. doi: 10.1111/j.1360-0443.2012.03889.x. Epub 2012 May 17. |
| 21330275 | Background | Bolam B, West R, Gunnell D. Does smoking cessation cause depression and anxiety? Findings from the ATTEMPT cohort. Nicotine Tob Res. 2011 Mar;13(3):209-14. doi: 10.1093/ntr/ntq244. Epub 2011 Feb 17. |
| 22038468 | Background | Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26. |
| 23100459 | Background | Weinberger AH, Mazure CM, Morlett A, McKee SA. Two decades of smoking cessation treatment research on smokers with depression: 1990-2010. Nicotine Tob Res. 2013 Jun;15(6):1014-31. doi: 10.1093/ntr/nts213. Epub 2012 Oct 25. |
| 39827790 | Derived | Rihs A, Schoeni A, Scharf T, Jakob J, Tal K, Jacot-Sadowski I, Humair JP, Frei A, Brutsche M, Rodondi N, Auer R, Baggio S. Effect of e-cigarettes for smoking cessation on depressive and anxiety symptoms: Secondary analysis of a randomized controlled trial. Gen Hosp Psychiatry. 2025 Mar-Apr;93:67-72. doi: 10.1016/j.genhosppsych.2025.01.011. Epub 2025 Jan 16. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
Not provided
Not provided