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The ESTxENDS Trial- Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) on Olfactory Function

Sponsor
University of Bern (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04617444
Collaborator
University of Lausanne (Other), University of Geneva, Switzerland (Other), University of Zurich (Other), State Hospital, St. Gallen (Other), Swiss National Science Foundation (Other), Krebsforschung Schweiz, Bern, Switzerland (Other), Federal Office of Public Health, Switzerland (Other)
389
Enrollment
5
Locations
2
Arms
32.8
Anticipated Duration (Months)
77.8
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Up to one in five people have suffered loss or impairment of their sense of smell, limiting their available information about the environment, including possible hazards (e.g. gas or smoke). An impaired sense of smell is strongly associated with smoking, but its prevalence in smokers has yet to be established. Since only a few prospective cohort studies among smokers have compared change in olfactory function in smokers, it is not known how much or how fast smoking may impair olfactory function. Some studies describe improvement in olfactory function among quitters, supporting anecdotal evidence from ex-smokers who say they regained their sense of smell over time. As far as the investigators know, no randomized controlled trial has tested the effects of a smoking cessation intervention on olfactory function.

A reliable and validated olfactory function test is the Burghart Sniffin' Sticks 16-item Identification-test, which is quick and easy to administer. 16 familiar odours will be presented to the participants, each for 3-4 seconds. After each odour the participant is asked to select the correct answer from 4 possible answers.

With increasing popularity of e-cigarettes, their effect on the olfactory function also needs to be assessed. It is known, that e-cigarettes produce toxic compounds such as carbonyl and aldehydes, what could impair the sense of smell - especially if the liquid-level is too low or the temperature on the coil is too hot. This is the source of a phenomenon called "dry-hit", which is said to leave a burnt taste or smell to be recognized by users. However, it is unclear if e-cigarettes users with an olfactory dysfunction can adequately recognize a "dry-hit". Therefore, the goal is to investigate the effects of smoking cessation and use of ENDS on olfactory function and the recognition of a "dry-hit" from a test e-cigarette.

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. All participants will be followed over a 24-month period. The primary objective is to assess changes in olfactory function from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.

Condition or Disease Intervention/Treatment Phase
  • Other: ENDS (vaporizer/e-cig) and smoking cessation counseling
  • Other: Smoking cessation counseling
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
389 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Statisticians and laboratory personnel will be blinded to group allocation
Primary Purpose:
Prevention
Official Title:
Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)
Actual Study Start Date :
Sep 7, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Other: 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.
Active Comparator: Control group

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Assessment of olfactory function- Baseline [Baseline]

    Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.

  2. Assessment of olfactory function- follow-up [6 months post quit date]]

    Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.

Secondary Outcome Measures

  1. Assessment of change of olfactory function [change from baseline to 6 months post quit date]

    Assessment of change of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.

  2. Assessment of dry-hit recognition [6 months post quit date]

    Assessment of dry-hit recognition. Participants will be given 2 ENDS to have them assess the probability of a dry-hit. The participants will be asked to rate the probability of a dry-hit in both ENDS as follows: Definitely (3 points) Probably (2 points) Probably not (1 points) Definitely not (0 points) 2 or 3 points will be interpreted as correctly identifying the ENDS generating a dry-hit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne Lausanne Vaud Switzerland 1011
2 University Clinic for General Internal Medicine, Bern University Hospital Bern Switzerland 3010
3 Département de médecine interne, Hôpitaux universitaires de Genève Geneva Switzerland 1211
4 Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen Saint Gallen Switzerland
5 Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich Zürich Switzerland

Sponsors and Collaborators

  • University of Bern
  • University of Lausanne
  • University of Geneva, Switzerland
  • University of Zurich
  • State Hospital, St. Gallen
  • Swiss National Science Foundation
  • Krebsforschung Schweiz, Bern, Switzerland
  • Federal Office of Public Health, Switzerland

Investigators

  • Study Director: Reto Auer, Prof.Dr.med, Berner Institut für Hausarztmedizin (BIHAM)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Bern
ClinicalTrials.gov Identifier:
NCT04617444
Other Study ID Numbers:
  • 2017-02332j
First Posted:
Nov 5, 2020
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 14, 2022