Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial)- Extension of Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Bern
- Enrollment
- 1,246
- Locations
- 5
- Primary Endpoint
- Validated 7-day point prevalence abstinence (1.1)
Study Overview
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. 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 60-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 6,12, 24, 60 months, participants will be asked to come to a clinical visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Statisticians and laboratory personnel will be blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 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
Arms & Interventions
Intervention group
Participants will received the Innokin Endura T20-S starter kit as intervention device. We use the e-liquids produced by the company Gaïatrend in France. Nicotine concentrations available will be 0 mg/ml, 6 mg/ml, 11 mg/ml and 19.6 mg/ml. Following aromas will be available to be chosen by the study participants: FR-4 (tobacco flavor) and FR-M (tobacco flavor), FRESH MINT (menthol flavor), RASPBERRY#2 (fruity flavor), RED FRUITS (fruity flavor) or GREEN APPLE (fruity flavor). The proportion of propylene glycol and vegetal glycerin will be 76/24 for all e-liquids. The components of the e-liquids will be propylene glycol, vegetal glycerin, medical-quality nicotine, alcohol and aromas.
Intervention: ENDS (vaporizer/e-cig) and smoking cessation counseling (Other)
Control group
Participants in the control intervention will receive standard-of-care (SOC) in form of smoking cessation counseling (SCC) only.
Intervention: Smoking cessation counseling (Other)
Outcomes
Primary Outcomes
Validated 7-day point prevalence abstinence (1.1)
Time Frame: 12 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).
Validated 7-day point prevalence abstinence (2.1)
Time Frame: 60 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).
Validated 7-day point prevalence abstinence (2)
Time Frame: 24 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).
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).
Secondary Outcomes
- Self-reported smoking abstinence allowing up to 5 cigarettes(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing up to 5 cigarettes (1)(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing up to 5 cigarettes (2)(12, 24 and 60 months post quit date)
- Number of cigarettes smoked per day (CPD)(12, 24 and 60 months post quit date)
- Change in number of cigarettes smoked per day (CPD)(12, 24 and 60 months post quit date)
- Use of any other smoking cessation products (NRT, Nicotine replacement therapy)(12, 24 and 60 months post quit date)
- Withdrawal(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing a 2-week'grace period' (2)(12, 24 and 60 months post quit date)
- Self-reported 7-day point prevalence abstinence(12, 24 and 60 months post quit date)
- Continuous smoking abstinence(12, 24 and 60 months post quit date)
- Continuous smoking abstinence (2)(12, 24 and 60 months post quit date)
- Self-reported smoking abstinence allowing a 2-week'grace period'(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing a 2-week'grace period' (1)(12, 24 and 60 months post quit date)
- Nicotine dependence(12, 24 and 60 months post quit date)
- Health-related quality of life(12, 24 and 60 months post quit date)
- Report on most common adverse events using ENDS(12, 24 and 60 months post quit date)
- Self-reported 7-day point prevalence abstinence(12, 24 and 60 months post quit date)
- Continuous smoking abstinence(12, 24 and 60 months post quit date)
- Continuous smoking abstinence (2)(12, 24 and 60 months post quit date)
- Self-reported smoking abstinence allowing a 2-week'grace period'(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing a 2-week'grace period' (1)(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing a 2-week'grace period' (2)(12, 24 and 60 months post quit date)
- Self-reported smoking abstinence allowing up to 5 cigarettes(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing up to 5 cigarettes (1)(12, 24 and 60 months post quit date)
- Validated smoking abstinence allowing up to 5 cigarettes (2)(12, 24 and 60 months post quit date)
- Number of cigarettes smoked per day (CPD)(12, 24 and 60 months post quit date)
- Change in number of cigarettes smoked per day (CPD)(12, 24 and 60 months post quit date)
- Use of any other smoking cessation products (NRT, Nicotine replacement therapy)(12, 24 and 60 months post quit date)
- Withdrawal(12, 24 and 60 months post quit date)
- Nicotine dependence(12, 24 and 60 months post quit date)
- Health-related quality of life(12, 24 and 60 months post quit date)
- Use of any ENDS(12, 24 and 60 months post quit date)
- Report on most common adverse events using ENDS(12, 24 and 60 months post quit date)