Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial)
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 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.


Options:
A: 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
B: Inclusion Criteria:

* Smoking 35 or more cigarettes per week or 5 or more cigarettes per day,
* Smoking for at least 2 years, with no period of abstinence longer than 3 months.

Exclusion Criteria:

* Using any smoking cessation drugs or nicotine replacement drugs in the last 3 months,
* Use of medication to treat depression or any psychiatric illness,
* Impaired renal function,
* Unstable medical condition,
* Pregnancy or breast feeding.
C: Inclusion Criteria:

* Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
* Enrolled in services at the research site for a minimum of 3 months
* Regular smoker (approximately 10 cigarettes for the past 5 years) with a history of at least 1 quit attempt
* Fluent in English

Exclusion Criteria:

* Regular use of e-cigarettes in the past month
* Current interest/plan to quit smoking
* Regular use of nicotine replacement therapy to quit smoking or use of bupropion or varenicline to quit smoking
* Use of emergency room or hospitalization for psychiatric reasons in the past 30 days
D: Inclusion Criteria:

Asthmatic symptoms during the last year and at least one criterion of the below:

1. current FEV1-increase of minimum 12% after b2-agonist,
2. positiv Methacholintest,
3. Day-to-day FEV1-variation of at least 20% during a two-week period.
4. Positive mannitol test.

Furthermore, all of the below inclusion criteria:

* At least 10 packyears
* At least 10 cigarettes per day within the last year
* Age 18-40 years

Exclusion Criteria:

1. Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists, anticholinergic medicine or varenicline within the last 3 months
2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks.
3. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded.
4. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period.
5. A history of allergy towards study drugs will lead to exclusion.

Patients who during the study period develop lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded, as well as patients who during the study period require more asthma medicine than the planned study medication.

Any participant who wishes to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended.

In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will result in exclusion and replacement of the participant.

Cessation of treatment with budesonide will result in exclusion from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used.

Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.

-

Answer: A