The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Sleep Quality.
NCT ID: NCT03603353
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1246 participants
INTERVENTIONAL
2018-07-16
2023-08-31
Brief Summary
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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.
The majority of attempts to quit tobacco smoking do not end in success due to unpleasant withdrawal symptoms. One of such symptoms is disturbed sleep. Sleep disturbances are a problem for smokers who are trying to quit. Sleep disturbances results from difficulty falling asleep or frequent arousals after sleep onset, and have negative daytime consequences such as sleepiness and dysphoric mood. Studies indicate that awakenings during night affect the cardiovascular system by providing repetitive bursts of sympathetic nervous system activation, likely contributing to elevated levels of cardiovascular and cerebrovascular morbidity. ENDS with nicotine containing e-liquids may be effective in assisting with tobacco smoking cessation by reducing withdrawal-induced sleep disturbances.
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.
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. Sleep quality will be assessed using the Pittsburgh sleep quality index- questionnaire at baseline and at 6, 12 and 24 months' follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
ENDS (vaporizer/e-cig) and smoking cessation counseling
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.
Control group
Smoking cessation counseling
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.
Interventions
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ENDS (vaporizer/e-cig) and smoking cessation counseling
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.
Smoking cessation counseling
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.
Eligibility Criteria
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Inclusion Criteria
* Persons aged 18 or older
* Currently smoking 5 or more cigarettes a day for at least 12 months
* Willing to try to quit smoking within the next 3 months,
* Persons providing a valid phone number, a valid email address and/or a valid postal address.
Exclusion Criteria
* Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
* Persons having used ENDS or tobacco heating systems regularly in the 3 months preceding the baseline visit
* Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
* Persons who cannot attend the 6- month follow-up visit for any reason
* Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures
18 Years
ALL
Yes
Sponsors
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University of Lausanne
OTHER
University of Geneva, Switzerland
OTHER
University of Zurich
OTHER
State Hospital, St. Gallen
OTHER_GOV
Swiss National Science Foundation
OTHER
Krebsforschung Schweiz, Bern, Switzerland
OTHER
Federal Office of Public Health, Switzerland
OTHER_GOV
University of Bern
OTHER
Responsible Party
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Principal Investigators
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Reto Auer, Prof.Dr.med
Role: STUDY_DIRECTOR
Berner Institut für Hausarztmedizin (BIHAM)
Micheline Maire, Dr.
Role: STUDY_DIRECTOR
Berner Institut für Hausarztmedizin (BIHAM)
Locations
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Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
Lausanne, Canton of Vaud, Switzerland
University Clinic for General Internal Medicine, Bern University Hospital
Bern, , Switzerland
Département de médecine interne, Hôpitaux universitaires de Genève
Geneva, , Switzerland
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
Zurich, , Switzerland
Countries
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References
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Hughes JR. Effects of abstinence from tobacco: etiology, animal models, epidemiology, and significance: a subjective review. Nicotine Tob Res. 2007 Mar;9(3):329-39. doi: 10.1080/14622200701188927.
Hughes JR, Higgins ST, Bickel WK. Nicotine withdrawal versus other drug withdrawal syndromes: similarities and dissimilarities. Addiction. 1994 Nov;89(11):1461-70. doi: 10.1111/j.1360-0443.1994.tb03744.x.
Wetter DW, Young TB. The relation between cigarette smoking and sleep disturbance. Prev Med. 1994 May;23(3):328-34. doi: 10.1006/pmed.1994.1046.
Colrain IM, Trinder J, Swan GE. The impact of smoking cessation on objective and subjective markers of sleep: review, synthesis, and recommendations. Nicotine Tob Res. 2004 Dec;6(6):913-25. doi: 10.1080/14622200412331324938.
Bertrand D. The possible contribution of neuronal nicotinic acetylcholine receptors in depression. Dialogues Clin Neurosci. 2005;7(3):207-16. doi: 10.31887/DCNS.2005.7.3/dbertrand.
Grandner MA, Jackson NJ, Pak VM, Gehrman PR. Sleep disturbance is associated with cardiovascular and metabolic disorders. J Sleep Res. 2012 Aug;21(4):427-33. doi: 10.1111/j.1365-2869.2011.00990.x. Epub 2011 Dec 12.
Other Identifiers
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2017-02332g
Identifier Type: -
Identifier Source: org_study_id
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