Please select the eligibility criteria that correspond to the clinical trial below.
Title: Computer-Assisted Guidance for Tobacco Dependence Interventions in Dental Offices
Brief Summary: Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.


Options:
A: 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
B: DISEASE CHARACTERISTICS:

* African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month

  * Not a heavy smoker
  * No other forms of tobacco within the past 30 days
* Must be interested in stopping smoking
* No other smoker in the household enrolled in this study

PATIENT CHARACTERISTICS:

* Has a home address and a functioning telephone number
* Not planning to move from the Kansas City metro area within the next 12 months
* Not pregnant or nursing
* Negative pregnancy test
* No alcohol or substance abuse within the past year
* Not currently drinking ≥ 14 alcoholic drinks per week
* No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
* No history of seizures or head trauma
* No history of bulimia or anorexia nervosa
* No myocardial infarction within the past 30 days
* No reported use of opiates, cocaine, or stimulants
* No diabetes requiring oral hypoglycemics or insulin

PRIOR CONCURRENT THERAPY:

* More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
* No other concurrent medication that contains bupropion hydrochloride
* No concurrent psychoactive medications
C: Inclusion Criteria:

* Adult dental patient presenting for an exam visit whose most recent history reports the patient is a smoker. Patients had to agree to the phone survey.

Exclusion Criteria:

* Research opt out list
* Patients who discontinued the survey prior to completion(considered withdrawals)
D: Inclusion Criteria:

1. Male or non-pregnant female cigarette smokers 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year;
2. Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
3. Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
4. Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
5. Subject must be able to complete all the study visits;
6. Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments;
7. Subject must be in good general health as determined by medical history, physical exam and physician investigator;
8. Subject must provide written informed consent to participate in the study;

Exclusion Criteria:

1. Subject is a female who is pregnant, lactating or likely to become pregnant during the trial and not willing to use an acceptable form of contraception during the medication phase, (for women of child-bearing potential, a pregnancy test will be performed prior to entry into the study and at the end of the medication phase);
2. Subject has another household member in study;
3. Known allergy to varenicline;
4. Subject is currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation program (i.e., behavioral therapy, nicotine replacement therapy, clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or unable to discontinue use;
5. Subject has an unstable medical condition as determined by the physician investigator;
6. Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia;
7. Subject has a personal history of renal failure or is on renal dialysis;
8. Subject has a current moderate or severe depression as assessed by the Center for Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
9. Subject has, as defined by the Columbia Suicide Severity Rating Scale (C-SSRS) current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
10. Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder;
11. Subject currently uses of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days;
12. Subject currently has cancer \[excluding non melanoma skin cancer\] not in remission (cancer free for 5 years or more);
13. Subject currently has Type 1 diabetes;
14. Subject has untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;
15. Subject is currently on treatment with another investigational drug (within 30 days of study entry);

Answer: C