Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: Inclusion Criteria:

* Smoker of at least 10 cigarettes daily
* Motivated to quit smoking
* Reports at least one unsuccessful attempt to quit in the last 2 years
* In generally good health
* Provides written informed consent to participate in the sudy

Exclusion Criteria:

* Pregnant or nursing females.
* Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter
* History of anaphylaxis
* History of alcohol or drug abuse
* History of or current significant medical or psychiatric disorder
* History or presence of cataract or abnormality identified by slit lamp investigation
* Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.
* Any medicine contraindicated for use with MAO inhibitors.
* Have or be a carrier of hepatitis B or c or HIV 1 or 2
* Use of tobacco products other than cigarettes
* Use of nicotine replacement therapy in the past month
* Received an investigational drug in the past 30 days
* Previous participation in a study with a MAO-B inhibitor
B: Inclusion Criteria:

* Smoker seeking treatment
* Aged 18 and over
* Consenting to take part
* Report little or no change in enjoyment of cigarettes and/or nausea

Exclusion Criteria:

* Pregnant or breastfeeding
* Have severe kidney disease
* Have severe heart problems
* Have a current psychiatric illness
* Are unable to fill in questionnaires in English
* Have an allergy to varenicline
* Are currently involved in another clinical trial
C: Inclusion Criteria:

* Smokes at least 10 cigarettes per day for at least the past 2 years
* Meets DSM-IV criteria for nicotine dependence, as determined by the Fagerstrom Nicotine Tolerance Questionnaire
* Meets DSM-IV diagnoses of unipolar depressive disorders (major depression, dysthymia, and minor depression)

Exclusion Criteria:

* Current suicidal or homicidal risk
* Serious illness, including cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or hematologic disease
* Untreated peptic ulcer
* Life-threatening arrhythmia, cerebrovascular, or cardiovascular event within the 6 months prior to enrollment
* Severe respiratory compromise, as defined as a FEV-1 less than 1.0 L/min and/or pO2 less than 60 or pCO2 less than 45
* Currently using nicotine-containing products (e.g., cigar, pipe, snuff, nicotine gum)
* History of a seizure disorder
* Current DSM-IV diagnosis of organic mental disorder, schizophrenia, delusional disorder, psychotic disorder, bipolar disorder, or antisocial personality disorder
* Current DSM-IV diagnosis of substance abuse or dependence disorders within the year prior to enrollment
* Current eating disorder, including anorexia nervosa and bulimia nervosa
* History of multiple adverse drug reactions or allergy to bupropion
* Mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs (with the exception of hypnotics and benzodiazepines at stable doses for at least six months prior to enrollment or current use of nonbenzodiazepine hypnotics such as Ambien and Sonata)
* Clinical or laboratory evidence of hypothyroidism
* Currently seeking treatment for smoking cessation
* History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, or tapes
* Currently using topical drugs
* Pregnant
* Not using adequate methods of contraception
D: 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.

Answer: A