Please select the eligibility criteria that correspond to the clinical trial below.
Title: Usefulness of Selegiline for Smoking Cessation
Brief Summary: Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.


Options:
A: Inclusion Criteria:

* Long-term, daily NRT users (except nicotine patch) (\>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
* More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
* more than 10 puffs of nasal spray per day.

Exclusion Criteria:

* Age \< 18 years,
* CO Smokers,
* Pregnant and lactating women,
* Used varenicline before,
* Not able to cooperate,
* Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air \> 7 ppm.
B: Inclusion Criteria:

* Meets DSM-IV criteria for nicotine dependence with a Fagerstrom Test of Nicotine Dependence (FTND) score greater than 5
* Smokes at least 15 cigarettes daily (averaged over 1 week, within the month prior to enrollment)
* Motivated to quit smoking within 30 days at time of initial evaluation
* At least one unsuccessful attempt to quit smoking in the past year
* An expired breath CO level greater than 10 ppm and baseline plasma cotinine level greater than 150 ng/ml at initial evaluation
* Body weight of at least 100 lb
* Avoidance of nicotine replacement product use one month prior to enrollment
* Speaks English

Exclusion Criteria:

* Currently taking over-the-counter or prescription sympathomimetic agents (e.g., pseudoephedrine, methylphenidate), antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
* Serious medical disorders such as unstable angina or liver failure
* Abnormalities in baseline bloodwork (e.g., threefold elevation of liver function tests, electrolyte abnormalities)
* Physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) during the 6 months prior to enrollment (based on a clinical evaluation, which includes a self-report, and is confirmed by a positive urine toxicology screen)
* Meets DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder, or post-traumatic stress disorder
* Current or past history of bipolar disorder or schizophrenia
* Past history of major depression associated with historical evidence of suicidal or homicidal behavior, or psychotic symptoms
* Currently residing with another study participant
* Presence of suicidal or homicidal ideation
* Significant impairment of social or occupational functioning, either at time of initial evaluation or during the trial
* Known hypersensitivity to selegiline hydrochloride
C: DISEASE CHARACTERISTICS:

* Smokes 10 or more cigarettes/day over the past year AND ≥ 5 cigarettes/day within the past week
* Planning to stop smoking in 4-6 weeks
* Member of Group Health Cooperative (GHC) and planning to stay enrolled for the next 6 months
* Eligible for the Free \& Clear program
* Enrolled in the COMPASS study using bupropion hydrochloride medication
* No prior participation in GHC's Free \& Clear smoking cessation program within the past 6 months

PATIENT CHARACTERISTICS:

* In good general health
* Sufficient verbal and written English
* Dependable access to a telephone and the Internet
* Not currently drinking ≥ 14 alcoholic drinks per week and/or binge drinking ≥ 2 times in the past month
* Not pregnant or nursing
* No plan to become pregnant
* No severe chronic heart disease (e.g, myocardial infarction within the past 3 months)
* No severe chronic obstructive pulmonary disease that ever required hospitalization or oxygen treatment
* No diagnosis of or treatment for a psychotic disorder (e.g., schizophrenia, bipolar disorder, or mania)
* Not having certain kidney problems

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent use of medications contraindicated with bupropion hydrochloride or known to lower seizure threshold (e.g., antidepressant, antipsychotic, monamine oxidase inhibitor, or protease inhibitor)
* No concurrent use of recreational or street drugs
* No concurrent use of bupropion hydrochloride or nicotine replacement therapy
* No concurrent cimetidine, metformin, phenformin, pindolol, procainamide
* Not on dialysis
D: Inclusion Criteria:

* Patients must be ≥ 18 years of age.
* Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:

  1. Lung or Bronchus cancer or Head \& Neck, cancers (all sites).
  2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
  3. Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies \[laser ablation,cervical conization, LEEP\].
* Having smoked at least 1 cigarette within 4 weeks of study enrollment.
* Having at least a 10-pack year history of cigarette smoking.
* Having smoked at least one cigarette within 1 month of cancer diagnosis.
* Life expectancy is greater than 1 year.
* Patient has an AUDIT score of \< 10.
* Patient has ECOG Performance Status of \<=2.
* Patients must have the ability to understand and the willingness to provide signed written informed consent document.

Exclusion Criteria:

* Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
* History of suicide attempt or preparation for attempt within the past 10 years.
* C-SRSS Baseline/Screening:

  1. Patient response of "Yes" to any question except question 1.
  2. Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
* Hospitalized for psychiatric illness within the past two years.
* History of Bipolar disorder.
* Currently taking Bupropion for depression.
* Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
* History of eating disorder such as anorexia or bulimia.
* Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
* History of epilepsy or seizure disorder.
* Active severe kidney or liver disease.
* Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
* Patients within three months of a myocardial infarction.
* Patients with unstable angina or serious arrhythmia.
* Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
* Patient taking varenicline or bupropion within one month of study enrollment.
* Participation in any other investigational drug study within 4 weeks of study enrollment.
* Currently enrolled in other professional tobacco cessation therapeutic intervention.
* Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.

Answer: B