Please select the eligibility criteria that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

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Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmHg systolic and/or \>90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

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B: Inclusion Criteria:

* Age 18+
* Smoke an average of at least five cigarettes per day for at least 1 year
* Breath CO levels \> 8 ppm (if ≤ 8 ppm, then NicAlert Strip \> 2)

Exclusion Criteria:

* Intention to quit smoking in the next 30 days
* Currently seeking treatment for smoking cessation
* Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
* A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
* Using other tobacco products more than 9 days in the past 30 days
* Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site)
* Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
* Schizophrenia and schizoaffective disorder
* Psychiatric medication changes in the past 3 months
* Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP

  1. Marijuana will be tested for but will not be an exclusionary criterion.
  2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
  3. Participants failing the toxicology screen will be allowed to re-screen once.
* Blood alcohol level \> 0.01

  a. Participants failing the blood alcohol screen will be allowed to re-screen once.
* Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male))
* Pregnant or breastfeeding
* Smoking 'roll your own cigarettes' exclusively
* Currently taking anticonvulsant medication
* CO reading \>80 ppm
* Systolic BP greater than or equal to 160

  a. Participants failing for blood pressure will be allowed to re-screen once.
* Diastolic BP greater than or equal to 100

  a. Participants failing for blood pressure will be allowed to re-screen once.
* Systolic BP below 90

  a. Participants failing for blood pressure will be allowed to re-screen once.
* Diastolic BP below 50

  a. Participants failing for blood pressure will be allowed to re-screen once.
* Heart rate greater than or equal to 115bpm

  a. Participants failing for heart rate will be allowed to re-screen once.
* Heart rate lower than 45bpm

  a. Participants failing for heart rate will be allowed to re-screen once.
* Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years
* Inability to independently read and comprehend the consent form and other written study materials and measures
* Having participated in a research study during the past three months in which the participant:

  1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day
  2. Used any tobacco products beyond normal use for more than one day
  3. Used any nicotine replacement products or smoking cessation medications for more than one day
C: Inclusion Criteria:

* smokers (at least 10 cigarettes/ day for the past year)
* willing to attempt quit smoking by using the National Health Service smoking cessation services or via e-cigarette use.

Exclusion Criteria:

* Non-ambulant people and people with a recent (e.g. within 6 months) cardiovascular disease event (e.g. stroke, myocardial infarction) or cardiac surgery,
* people with insulin-controlled diabetes mellitus or with coexisting skin conditions, leg ulcers, vasculitis or deep venous occlusion (as these may affect their cardiovascular function),
* pregnant women,
* people who require major surgery (which will prevent them of taking part in the study)
* people who following referral to the smoking cessation services, are advised that Nicotine Replacement Therapy is not appropriate for them,
* people who are currently using e-cigarettes on a daily basis, or currently undertaking an attempt within a smoking cessation service,
* people who are judged to be unable or are unwilling to give informed consent.

The study team will assess prospective participants and will not include in the study those who appear too frail or have health problems (e.g. dementia, Alzheimer's etc.) that might prevent them of giving a conscious, informed consent.
D: Inclusion Criteria:

* Healthy on the basis of medical history
* Current moderate-to-heavy smoker as determined by:

  * Has smoked \>=10 cigarettes per day regularly for the past year (by history) and (\>=5 cigarettes per day Study 2 ONLY)
  * Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY)
* Nicotine dependence assessed as \> 4 with the Fagerstrom Test for Nicotine Dependence
* Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
* Pregnancy or lactation (by history) or positive pregnancy test at screening visit
* Positive urine drug test at screening visit
* History of serious side effects from nicotine or from any nicotine replacement therapies
* Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
* Concurrent participation in another clinical trial
* Unable to communicate in English
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Answer: A