Please select the eligibility criteria that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: Inclusion Criteria:

1. Age ≥ 18 years at the day of consenting to the study (or at the day of randomization for cohort B patients not included in the global study)
2. Patients with OPML: at least one lesion ≥ 5 mm (Cohort A only)
3. Patients with surgically resectable HNSCC not treated with preoperative chemotherapy, pT1-4 N0-3 M0 (Cohort B only)
4. Patients with surgically resectable HNSCC not treated with preoperative chemotherapy and non-eligible to cohort B (Cohort C only)
5. PS ECOG ≤ 1
6. Treatment plan incorporating surgery and radiation therapy (or at the day of randomization for cohort B patients not included in the global study)
7. Smoker = Adult who have smoked at least 100 cigarettes in his/her lifetime (Cohort B only)
8. Current smoker (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smoker (who says he/she doesn't smoke) who stops smoking within 3 months prior to diagnosis (Cohort B only)
9. Motivation to quit smoking evaluated by the Richmond test (Cohort B only)
10. Without subordination motivation to quit smoking (Cohort B only)
11. Covered by a medical insurance
12. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment

Exclusion Criteria:

1. Non-stabilized cognitive disorder
2. Synchronous malignancy (Cohort A only)
3. History of malignant disease outside the upper aerodigestive tract, except skin carcinoma
4. Substance use disorder other than smoking (cigarette and cannabis) and alcohol (Cohort B only)
5. Use of nicotine replacement therapy, bupropion, varenicline on last 3 months (Cohort B only)
6. Undergoing on last 3 months' behavioral and cognitive therapy for smoking cessation (Cohort B only)
7. Patient included in a clinical trial evaluating interventions for smoking cessation (Cohort B only)
8. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
9. Pregnant or breastfeeding woman
B: Inclusion Criteria:

1. Age: 18-65 years old
2. Smoking: \>/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
3. Able to follow verbal and written instructions in English and complete all aspects of the study
4. Have an address and home telephone number where they may be reached
5. Provide informed consent and agree to all assessments and study procedures
6. Be the only participant in their household

Exclusion Criteria:

1. Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study
2. Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
3. Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
4. Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
5. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
6. Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
7. Severe renal impairment (CR Clearance \<30 ml/min/1.73 m2).
8. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
9. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
10. Subject rated as moderate to high on suicidality as assessed by the MINI.
11. Psychiatric hospitalization within 1 year of screening date.
12. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
13. Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
14. Use of Varenicline or Bupropion within two weeks before the screening visit.
15. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
16. 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.
C: Inclusion Criteria:

* Receives dental care from a participating practitioner;
* Is age 18 or older;
* Self-reports tobacco use within the past month;
* Willing to comply with all study procedures and be available for the duration of the study;
* Willing to provide verbal informed consent;
* Has access to a telephone, and agrees to receive text messages, emails, or telephone calls related to the study. (The patient's preferred method of contact will be ascertained).
* Willing to be contacted on a regular basis by each of these entities: the practice;Regional Coordinators (RC) and/or University of Kentucky (UK) researchers; and
* Willing to provide contact information of one person living at a different address who will know the patient's whereabouts in the event the patient cannot be reached.

Exclusion Criteria:

* Psychiatric disability or mental illness judged by the practitioner to be clinically significant so as to preclude informed consent or compliance with procedures of study visits.
* Cognitive impairment judged by the practitioner to be significant so as to preclude informed consent or compliance with procedures of study visits.
D: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
* Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
* Smokes at least 20 cigarettes per day (1 pack per day)
* Expired breath CO level \> 10 ppm and cotinine level \> 210 ng/ml at the baseline measurement
* Currently taking a stable dose of antipsychotic
* Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation

Exclusion Criteria:

* Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
* History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
* Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
* Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
* Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
* History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

Answer: D