Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
Brief Summary: This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.


Options:
A: Inclusion Criteria:

* Active conventional cigarette smoker

Exclusion Criteria:

* Health condition adversely affected by smoking, history or presence of cardiovascular disease
B: Inclusion Criteria:

* resident into the Abruzzo and Lazio Region
* aged between 30 and 75 years;
* smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
* smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
* smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).

Exclusion Criteria:

* illicit drug use,
* breastfeeding or pregnancy,
* major depression or other psychiatric conditions,
* severe allergies,
* active antihypertensive medication,
* angina pectoris,
* past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.
C: 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
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: D