Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Brief Dental Office Intervention With Tobacco Quitline
Brief Summary: The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.


Options:
A: Inclusion Criteria:

Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

Exclusionary criteria are: planning a pregnancy, pregnancy, lactating, seizure disorder, history of head trauma or prior seizure, family history of a seizure disorder, brain (or CNS) tumor, history of or currently diagnosed with bulimia or anorexia nervosa, diabetes treated with oral hypoglycemics or insulin, excessive use of alcohol or alcoholism, current addiction to opiates, cocaine, or stimulants, use of other drugs containing bupropion (e.g., Wellbutrin, Wellbutrin SR), allergy to bupropion, currently taking particular medications (e.g., monoamine oxidase inhibitor, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics), recently taken a MAOI (less than 14 days) or a recent discontinuation of a benzodiazepine.
B: 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
C: Patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.
D: 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

Answer: C