Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning: Design of a Randomized Trial. Smoking Cessation And Reduction In Schizophrenia (The SCARIS Study)
Brief Summary: It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.


Options:
A: Inclusion Criteria:

* males and females
* over age 18
* used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
* residing within 100km of New Dehli for the next 4 months
* interested in quitting use of smokeless tobacco.

Exclusion Criteria:

* currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
* plan to use other smoking cessation treatments in the next 4 months
* smoke cigarettes
* have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
* have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
* Current use or discontinuation within last 14 days of:

  1. smoking cessation medications (bupropion, Varenicline, NRT);
  2. antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
  3. Anti-coagulants;
  4. Daily medication for asthma or diabetes (eligible with physician approval);
* are pregnant, planning a pregnancy, or lactating
* have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
* have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
* have an allergy to Varenicline
* ever contemplated or attempted suicide
* have serious/unstable disease within the past 6 months (e.g., cancer \[but melanoma\], heart disease, HIV/AIDS)
* have a history of epilepsy or seizure disorder
* have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (\>100 beats/minute)
* have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP\>150 or DBP\>90)16)
* have a history of kidney or liver failure
* have any medical condition or medication that could compromise safety as determined by a study physician
* cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
B: Inclusion Criteria:

Subjects will be eligible to participate if they:

1. Are at least 18 years of age
2. Have used ST daily for the past 12 months (regular user)
3. Identify ST as their primary tobacco product
4. Are in general good health (determined by medical history and screening physical examination)
5. Has provided written informed consent to participate
6. Are able to participate in all aspects of the study

Exclusion Criteria:

Individuals will be excluded from study participation if they:

1. Are currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation programs (i.e., behavioral therapy, nicotine replacement therapy, clonidine, bupropion SR, or doxepin)
2. Have self-reported current, untreated depression or a Beck Depression Inventory (BDI-II) Score of ≥ 20
3. Have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale);current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.")
4. History of psychosis or bipolar disorder
5. Are currently pregnant or lactating or is of childbearing potential and not willing to use any form of contraception
6. Have another member of their household already participating in this study
7. Are allergic to varenicline
8. Describe having a medical history of:

   * Unstable angina
   * Myocardial infarction within the past 3 months
   * Cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT
   * Medically-treated or untreated hypertension with BP ≥ 200 systolic OR ≥ 100 diastolic
   * Have other medical or psychiatric conditions that would exclude the participant
C: Inclusion Criteria:

* Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness.
* smoke ≥10 factory made cig/day, for at least the past five years
* age 18-65 years
* in good general health
* not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months
* committed to follow the trial procedures.

Exclusion Criteria:

* use of smokeless tobacco or nicotine replacement therapy
* pregnancy or breastfeeding.
* current or recent (less than 1 yr) past history of alcohol and/or drug abuse
* other significant co-morbidities according to the Investigator's clinical assessment
D: Inclusion Criteria:

* Males and females between 18 and 55 years old will be eligible for this study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
* Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
* Subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for opioid dependence.
* Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days.
* Subjects must meet DSM-IV criteria for cocaine dependence or abuse, and have laboratory confirmation of recent cocaine use (positive urine for cocaine) during the month prior to study entry.
* Subjects must be treatment-seekers for opioid and cocaine use.
* Subjects must have smoked at least 10 cigarette per day for at least one year. Varenicline's safety has only been studied in smokers.

Exclusion Criteria:

* History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
* History of severe renal or hepatic diseases.
* History of psychosis, schizophrenia, bipolar or major depressive disorder.
* History of seizure disorder.
* Current diagnosis of alcohol, benzodiazepine and other drug abuse or dependence (other than opiates, cocaine, and nicotine).
* Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
* Liver function tests (ALT or AST) greater than 3 times normal.
* Known allergy to varenicline or methadone.

Answer: C