Please select the eligibility criteria that correspond to the clinical trial below.
Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: Inclusion Criteria:

* smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
* tested positive for urine cotinine (≥ 200 ng/mL) at Screening
* exhaled carbon monoxide \> 10 ppm (parts per million) at Screening

Exclusion Criteria:

* relevant illness history
* relevant medication use
* body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
* allergy to propylene glycol or glycerin
* use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
* use of any prescription smoking cessation treatments within 3 months prior to Check-in
* smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
* planning to quit smoking during the study
* female subjects who are pregnant, lactating, or intend to become pregnant
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:

* Active conventional cigarette smoker

Exclusion Criteria:

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

* Smoke and want to quit in the next three months
* Reside in New Zealand
* At least 18 years of age
* Able to provide verbal consent
* Have access to telephone (mobile and/or landline)
* Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
* Only one person per household is eligible.

Exclusion Criteria:

* Pregnant women
* Women who are breastfeeding
* Current users of NRT products
* People currently enrolled in another smoking cessation programme or other cessation study
* People who have used an e-cigarette for more than one week in the last year for smoking cessation
* Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline).
* People who have had a heart attack, stroke or severe angina within the previous two weeks.
* People who self-report a history of severe allergies and/or poorly controlled asthma.

Answer: B