Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention
Brief Summary: The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research-dental office interventions and telephone help line effectiveness-led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.


Options:
A: Inclusion Criteria:

* Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion Criteria:

* Smoking Behavior

  1. Use of chewing tobacco or snuff
  2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
  3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
  4. Provide a baseline CO reading \< 10 ppm

Alcohol/Drug Exclusion Criteria

1. History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
2. Current alcohol consumption that exceeds \>25 standard drinks/week

Medication Exclusion Criteria

1. Current use or recent discontinuation (within last 14-days) of the following medications:

1. Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
2. Any form of anti-psychotic medications that includes:

   * antipsychotics,
   * atypical antipsychotics,
   * mood-stabilizers,
   * anti-depressants (tricyclics, SSRI's, MAOI's),
   * anti-panic agents,
   * anti-obsessive agents,
   * anti-anxiety agents, and
   * stimulants (e.g., Provigil, Ritalin).
3. Medication for chronic pain
4. Anti-coagulants
5. Any heart medications
6. Daily medication for asthma

Medical Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating.
2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
3. Serious or unstable disease within the past 6 months (e.g., cancer \[except melanoma\], heart disease, HIV).
4. History of epilepsy or a seizure disorder.
5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (\>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP\>150 or DBP\>90)
6. History of Kidney and/or liver failure (including transplant).
7. Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
8. Hearing threshold \< 40 dB SPL at 1000 Hz.
9. Color blindness.

General Exclusion

1. Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
B: Inclusion Criteria:

* Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
* Dentists in private practice, employing at least one dental hygienist and one dental assistant.

Exclusion Criteria:

* Dental patients under the age of 18
C: 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.
D: Inclusion Criteria:

* daily smoker
* 5+ cigarettes per day for at least one year
* expired carbon monoxide level of 5+ ppm

Exclusion Criteria:

* current use of smoking cessation pharmacotherapies
* current or history of psychotic disorder
* current major depressive disorder
* history of suicidal ideation in the previous 3 months
* unstable medical condition
* pregnant, nursing, or planning to become pregnant
* planning to move from study area within 18 months

Answer: B