Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The ESTxENDS Trial- Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cigarette) as an Aid for Smoking Cessation. (ESTxENDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03589989
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
University of Lausanne
University of Geneva, Switzerland
Swiss National Science Foundation
Information provided by (Responsible Party):
University of Bern

Brief Summary:

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. In addition, ENDS do not lead to higher 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 6-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 months, participants will be asked to come to a final clinical visit.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: ENDS (vaporizer/e-cig) and smoking cessation counseling Other: Smoking cessation counseling Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1172 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 (The ESTxENDS Trial)
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 6-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 months, participants will be asked to come to a final 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 6-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 months, participants will be asked to come to a final clinical visit.




Primary Outcome Measures :
  1. Continuous smoking abstinence (1) [ Time Frame: 6 months post quit date ]
    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).


Secondary Outcome Measures :
  1. Continuous smoking abstinence (2) [ Time Frame: 6 months post quit date ]
    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).

  2. Self-reported smoking abstinence allowing a 2-week`grace period' [ Time Frame: 4, 8 weeks and 6 months post quit date ]
    Smoking abstinence allowing a 2-week`grace period' after the target quit date.

  3. Validated smoking abstinence allowing a 2-week`grace period' (1) [ Time Frame: 6 months post quit date ]
    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).

  4. Validated smoking abstinence allowing a 2-week`grace period' (2) [ Time Frame: 6 months post quit date ]
    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).

  5. Self-reported smoking abstinence allowing up to 5 cigarettes [ Time Frame: 1, 2, 4, 8 weeks and 6 months post quit date ]
    Smoking abstinence allowing up to 5 cigarettes in total after the target quit date.

  6. Validated smoking abstinence allowing up to 5 cigarettes (1) [ Time Frame: 6 months post quit date ]
    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).

  7. Validated smoking abstinence allowing up to 5 cigarettes (2) [ Time Frame: 6 months post quit date ]
    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).

  8. Self-reported 7-day point prevalence abstinence [ Time Frame: 1, 2, 4, 8 weeks and 6 months post quit date ]
    Self-report of having smoked no cigarettes in the past seven days.

  9. Validated 7-day point prevalence abstinence (1) [ Time Frame: 6 months post quit date ]
    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).

  10. Validated 7-day point prevalence abstinence (2) [ Time Frame: 6 months post quit date ]
    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).

  11. Number of cigarettes smoked per day (CPD) [ Time Frame: baseline, target quit date, 1, 2, 4, 8 weeks and 6 months post quit date ]
    self-reported

  12. Change in number of cigarettes smoked per day (CPD) [ Time Frame: baseline, 6 months post quit date ]
    self-reported. Successful reduction defined as 50% reduction in CPD.

  13. Use of any other smoking cessation products (NRT, Nicotine replacement therapy) [ Time Frame: 1, 2, 4, 8 weeks and 6 months post quit date ]
    self-reported on whether and how often they used any NRT.

  14. Withdrawal [ Time Frame: baseline and 6 months post quit date ]
    The physical signs and symptoms associated with withdrawal, measured using the Minnesota Tobacco Withdrawal Scale (http://www.med.uvm.edu/behaviorandhealth/minnwsdefault). 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.

  15. Nicotine dependence [ Time Frame: baseline and 6 months post quit date ]
    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.

  16. Health-related quality of life [ Time Frame: baseline and 6 months post quit date ]
    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.

  17. Use of any ENDS [ Time Frame: 1, 2, 4, 8 weeks and 6 months post quit date ]
    self-reported on whether and how often they used any ENDS

  18. Report on most common adverse events using ENDS [ Time Frame: 1, 2, 4, 8 weeks and 6 months post quit date ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 study
  • Persons having used ENDS regularly in the 3 months preceding the baseline visit
  • Persons having used nicotine replacement therapy (NRT) or other drug therapy helping smokers quit (varenicline, bupropion) within the 3 months preceding the baseline visit
  • Plans to move out of the country within the next 6 months, or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589989


Contacts
Layout table for location contacts
Contact: Reto Auer, Prof.Dr.med +41 31 631 58 79 reto.auer@biham.unibe.ch
Contact: Anna Schöni, Dr. +41 31 631 58 66 anna.schoeni@biham.unibe.ch

Locations
Layout table for location information
Switzerland
Policlinique Médicale Universitaire, Université de Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Jacques Cornuz, Prof.Dr.med       Jacques.Cornuz@chuv.ch   
University Clinic for General Internal Medicine, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Nicolas Rodondi, Prof.Dr.med       Nicolas.Rodondi@insel.ch   
Département de médecine interne, Hôpitaux universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Contact: Jean-Paul Humair, PD Dr.med.       Jean-Paul.Humair@hcuge.ch   
Sponsors and Collaborators
University of Bern
University of Lausanne
University of Geneva, Switzerland
Swiss National Science Foundation
Investigators
Layout table for investigator information
Study Director: Reto Auer, Prof.Dr.med Berner Institut für Hausarztmedizin; Universität Bern

Publications:

Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03589989     History of Changes
Other Study ID Numbers: 2017-02332
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action