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:

1. Between the ages of 18 and 75.
2. Smoking 5 or more cigarettes per occasion at least 3 times per week.
3. Fewer than 3 months of smoking abstinence in the past year.
4. Motivated to stop smoking.
5. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion.

Exclusion Criteria:

1. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
2. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
3. Clinically significant cardiovascular disease
4. Uncontrolled hypertension
5. Hepatic or renal impairment
6. Severe chronic obstructive pulmonary disease
7. Diabetes mellitus requiring insulin or oral hypoglycemic medications.
8. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
9. History of cancer (except treated basal cell or squamous cell carcinoma of the skin).
10. History of clinically significant allergic reactions.
11. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination)
12. Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.
13. Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of \> 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal.
14. Use of another investigational drug within 30 days.
15. Intention to donate blood or blood products during the treatment phase of the study.
16. Use of tobacco products other than cigarettes or use of marijuana.
17. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication.
18. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.
19. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
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:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)
D: Inclusion Criteria:

1. Between the ages of 18 and 75
2. Smoking 10 or more cigarettes per day
3. Fewer than 3 months of smoking abstinence in the past year
4. Motivated to stop smoking

Exclusion Criteria:

1. Current use of opiates, and/or a urine toxicology screen positive for opiates
2. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
3. Evidence of significant hepatocellular injury as evidence by AST or ALT \>3 x normal or elevated bilirubin
4. History of cirrhosis
5. Any serious or unstable disease within 6 months
6. Seizure risk
7. Diabetes mellitus requiring insulin or oral hypoglycemic medications
8. Hepatic or renal impairment
9. Use of a monoamine oxidase inhibitor in the prior 14 days
10. Clinically significant cardiovascular disease within 6 months
11. Uncontrolled hypertension
12. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
13. Severe chronic obstructive pulmonary disease
14. History of cancer (except treated basal cell or squamous cell carcinoma of the skin)
15. History of clinically significant allergic reactions
16. Major depressive disorder within the past year requiring treatment
17. History of or current panic disorder, psychosis, bipolar disorder, or eating disorders
18. Alcohol or drug abuse/dependency within the past year
19. Use of another investigational drug within 30 days
20. Intention to donate blood or blood products during the treatment phase of the study
21. Use of tobacco products other than cigarettes or use of marijuana
22. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication
23. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.
24. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermacide)

Answer: B