Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: Inclusion Criteria:

* Age 18-64
* Regular ten cigarette per day smoker for one year
* Nicotine Dependency Score greater than or equal to four
* DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
* Psychiatric medication regimen unchanged for at least 90 days
* Psychiatric medication dosage unchanged for at least 30 days

Exclusion Criteria:

* Psychiatric hospitalization in last 6 months
* Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
* Suicide or homicide ideation with a plan in the last six months
* Life time history of suicide attempt
* Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
* Current treatment with Bupropion SR
* DSM-IV diagnosis of alcohol or substance dependence within last 6 months\*
* DSM-IV diagnosis of alcohol or substance abuse within three months \*
* Pregnancy or lactation in females (+HCG)
* Use of tobacco product other than cigarettes
* Use of nicotine replacements
* Unstable or serious medical condition in last 6 months
* Regular use of cimetidine (OTC or Rx) \*Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
B: 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.
C: Inclusion Criteria:

* Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then positive cotinine test)
* Interested in treatment that might change smoking behavior
* Able to follow verbal and written instructions in English and complete all aspects of the study
* Provide informed consent and agree to all assessments and study procedures
* Have an address and telephone number where he/she may be reached
* Be the only participant in his/her household

Exclusion Criteria:

* Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
* Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
* Plan to use other nicotine substitutes (i.e., over-the-counter \[OTC\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
* Uncontrolled hypertension (systolic blood pressure; \[SBP\] greater than 180 or diastolic blood pressure; \[DBP\] greater than 110)
* History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
* Laboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigator
* Serious or unstable disease within the past 3 months
* History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
* Current use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month's duration)
* Meet criteria for the following psychiatric and/or substance use disorders as assessed by the MINI International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum - past 6 months only; current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physician
* Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI
* Psychiatric hospitalization within 1 year of screening date
* A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
* Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
* History of hypersensitivity or allergic reaction to varenicline, NRT, or any component of these formulations
* Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
* Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study
* Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or tetrahydrocannabinol (THC); a. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; b. participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return; study physician may clear participant to continue on if there is a reasonable possibility the positive drug screen is the result of cross-reactivity with the participant's concomitant medications resulting in a false positive
D: Inclusion Criteria:

1. be male or female, 18 years of age or older
2. be able to understand the study, and having understood, provide written informed consent in English
3. have been enrolled in the University of Cincinnati Physicians Company-Opioid Treatment Program (UCPC-OTP) program for at least 30 days and be stable on the current methadone dose for at least 1 week
4. have smoked cigarettes for at least 3 months, have a measured exhaled carbon monoxide (CO) level \> 8 parts per million (ppm), and not planning to seek smoking-cessation treatment within the next 3 months
5. have a willingness to comply with all study procedures, including trying to stop smoking during designated weeks, and to comply with medication instructions
6. based on a week of Quitbit cigarette lighter assessments, with at least 5 days of usable data, smoke ≥ 10 cigarettes/day and smoke at least 30% of daily cigarettes within the 4-hour post-methadone-dosing period
7. if female and of child bearing potential, agree to use one of the following methods of birth control: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection,complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring.

Exclusion Criteria:

1. have a current or past diagnosis of any psychotic disorder, or bipolar I or II disorder
2. have a psychiatric condition that, in the judgment of the study physician would make study participation unsafe or which would make treatment compliance difficult
3. be a significant suicidal/homicidal risk
4. have a medical condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Such conditions include, but are not limited to:

   * liver function tests greater than 3 times upper limit of normal
   * serum creatinine greater than 2 mg/dL
5. have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities
6. have taken an investigational drug within 30 days before consent
7. be taking concomitant medications that are contraindicated for use with the NNS or varenicline
8. be taking any concomitant medications that could increase the likelihood of smoking cessation (such as wellbutrin or nortriptyline)
9. have a known or suspected hypersensitivity to varenicline or the nicotine nasal spray (NNS)
10. use/have used smoking-cessation counseling programs with individual counseling or smoking-cessation medication treatments currently, or within 30 days before consent
11. have used electronic cigarettes or tobacco products, other than cigarettes, in the week before consent
12. be pregnant or breastfeeding
13. be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)

Answer: B