Nicotine-containing e-cigarettes (Vaporizers) to support smoking cessation: Benefits, safety, and toxicology
Summary description of the study
Around 1200 individuals aiming to quit smoking will be individually followed for 6 months as part of the study. To determine whether e-cigarettes (vaporizers) are more effective compared to smoking cessation counseling alone, participants will be randomly assigned to two groups. Half of the participants (‘intervention group’) will receive an e-cigarette (vaporizer) with nicotine-containing refill liquids (e-liquids) that they can use as often as they wish. Additionally, participants will receive smoking cessation counseling at several points in time. The second half of the participants (‘control group’) will receive only the smoking cessation counseling.
(BASEC)
Intervention under investigation
Half of the participants (‘intervention group’) will receive an e-cigarette (vaporizer) with nicotine-containing refill liquids (e-liquids) that they can use as often as they wish. Additionally, participants will receive smoking cessation counseling at several points in time. The second half of the participants (‘control group’) will receive only the smoking cessation counseling. Participants in the control group can receive a voucher worth 30 CHF at the end of the study. All participants, including those in the intervention group, can use additional smoking cessation aids (e.g., nicotine patches, gum) at their own expense, but this must be communicated to the study physician.
(BASEC)
Disease under investigation
Smoking is the most common preventable cause of death in Switzerland. Smokers who aim to quit or wish to reduce their exposure to harmful substances are increasingly turning to tobacco-free electronic cigarettes, also known as vaporizers. In these vaporizers, a nicotine-containing refill liquid (known as e-liquid) is heated into vapor, which can be inhaled. Refill liquids are available in various flavors with or without nicotine content. Currently, it is still controversial whether nicotine-containing e-cigarettes (vaporizers) are useful for supporting smoking cessation. Preliminary studies from other countries suggest so, but they are not yet very conclusive, as the number of individuals studied was small. There are currently few controlled studies on the safety of e-cigarettes (vaporizers).
(BASEC)
Smokers who have been smoking 5 or more cigarettes daily for at least 12 months and are over 18 years old. (BASEC)
Exclusion criteria
Pregnant and breastfeeding women, as well as women planning a pregnancy in the next 6 months, are not allowed to participate. (BASEC)
Trial sites
Bern, Geneva, Lausanne, St. Gallen, Zurich
(BASEC)
Sponsor
Universität Bern
(BASEC)
Contact
Contact Person Switzerland
Reto Auer
+41 31 684 58 79
reto.auer@clutterunibe.chUniversität Bern Berner Institut für Hausarztmedizin (BIHAM) Represented by: Prof. Dr. med. Reto Auer Mittelstrasse 43 3012 Bern Schweiz
(BASEC)
General Information
Berner Institut für Hausarztmedizin, Universität Bern,
+41 31 631 58 79
reto.auer@clutterunibe.ch(ICTRP)
Scientific Information
Berner Institut für Hausarztmedizin, Universität Bern,
+41 31 631 58 79
reto.auer@clutterunibe.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
27.04.2018
(BASEC)
ICTRP Trial ID
NCT03589989 (ICTRP)
Official title (approved by ethics committee)
Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an aid for smoking cessation: The ESTxENDS multicentre randomized controlled trial (BASEC)
Academic title
Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial) (ICTRP)
Public title
The ESTxENDS Trial- Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cigarette) as an Aid for Smoking Cessation. (ICTRP)
Disease under investigation
Smoking Cessation (ICTRP)
Intervention under investigation
Other: ENDS (vaporizer/e-cig) and smoking cessation counseling;Other: Smoking cessation counseling (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Informed Consent as documented by signature
- 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:
- Known hypersensitivity or allergy to contents of the e-liquid
- 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 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
(ICTRP)
not available
Primary and secondary end points
Continuous smoking abstinence (1) (ICTRP)
Continuous smoking abstinence (2);Self-reported smoking abstinence allowing a 2-week'grace period';Validated smoking abstinence allowing a 2-week'grace period' (1);Validated smoking abstinence allowing a 2-week'grace period' (2);Self-reported smoking abstinence allowing up to 5 cigarettes;Validated smoking abstinence allowing up to 5 cigarettes (1);Validated smoking abstinence allowing up to 5 cigarettes (2);Self-reported 7-day point prevalence abstinence;Validated 7-day point prevalence abstinence (1);Validated 7-day point prevalence abstinence (2);Number of cigarettes smoked per day (CPD);Change in number of cigarettes smoked per day (CPD);Use of any other smoking cessation products (NRT, Nicotine replacement therapy);Withdrawal;Nicotine dependence;Health-related quality of life;Use of any ENDS;Report on most common adverse events using ENDS (ICTRP)
Registration date
19.06.2018 (ICTRP)
Incorporation of the first participant
16.07.2018 (ICTRP)
Secondary sponsors
University of Lausanne;University of Geneva, Switzerland;University of Zurich;State Hospital, St. Gallen;Swiss National Science Foundation (ICTRP)
Additional contacts
Reto Auer, Prof.Dr.med;Reto Auer, Prof.Dr.med, reto.auer@biham.unibe.ch, +41 31 631 58 79, Berner Institut für Hausarztmedizin, Universität Bern, (ICTRP)
Secondary trial IDs
2017-02332 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/show/NCT03589989 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available