Please select the eligibility criteria that correspond to the clinical trial below.
Title: Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
Brief Summary: People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher.

Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes.

Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.


Options:
A: 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
B: Inclusion Criteria:

* smokers (≥ 5 cigarettes/day for \> 1 yr and breath CO \> 5 ppm)
* ages 18-65 years
* ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder

Exclusion Criteria:

* used e-cigs on \> 2 occasions in the past 30 days;
* intend to quit smoking within the next 30 days;
* currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram);
* have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days);
* People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke).
* People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland).
* People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland
* met DSM-IV criteria for drug dependence
* have medical contraindications to nicotine, since nicotine intake may increase in this study;
* have past-month suicidal ideation or past-year suicide attempt.
* are pregnant, as determined through a pregnancy test
C: Inclusion Criteria:

* Vitality beneficiary
* 18 years or older
* reported and/or tested positive for being a smoker
* all participants will be able to opt-out of this program.

Exclusion Criteria:

* Participants who express wanting to opt-out of this program will be un-enrolled and excluded
D: Inclusion Criteria:

* \> 21 years of age
* Smoked cigarettes on \> 25 of past 30 days
* Smoked \> 5 cigarettes per day on days smoked
* Smoked cigarettes \> 6 months
* Carbon monoxide \> 5 PPM at baseline
* Hispanic/Latino or African American/Black
* Fluent in English or Spanish
* Willing to switch from smoking cigarettes to ECs for 6 weeks
* Regular access to telephone
* Transportation to attend appointments (KC Only)

Exclusion Criteria:

* Primary use of other tobacco products or equal use of cigarettes and other tobacco products
* Electronic cigarette use on \> 4 of the past 30 days
* Currently in a smoking cessation program or another clinical trial
* Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days
* Hospitalization for a psychiatric issue in the past 30 days
* Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease
* Uncontrolled blood pressure at baseline
* Planning to move out of San Diego or Kansas City in the next 6 weeks
* Another person in the household enrolled in the study
* Women: pregnant, breastfeeding, or planning to become pregnant in the next six months
* Unstable mental status or health status

Answer: B