Please select the eligibility criteria that correspond to the clinical trial below.
Title: Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation
Brief Summary: Research Aims

The aims of this research study are:

1. To determine which of the following three smoking cessation medications is most effective in achieving cessation:

   * Nicotine Patch
   * Nicotine Patch + gum or inhaler
   * Varenicline (Champix;
2. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether:

   * They occur more often when taking one medication versus another
   * They occur more often in those with or without psychiatric illnesses.

Hypotheses to be Tested

The hypotheses to be tested include the following:

1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone.
2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.


Options:
A: We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

Inclusion Criteria:

a. To be eligible for the Comparative effectiveness trial, participants must:

* smoke 5 or more cigarettes per day,
* desire to quit smoking but not be currently engaged in cessation treatment,
* be medically eligible to use either combination NRT or varenicline,
* have reliable phone access,
* if female, must not be pregnant and must be willing to use an acceptable birth control method.

Exclusion Criteria:

1. There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
2. All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:

   * end-stage renal disease with hemodialysis;
   * prior suicide attempts within the last 5 years or current suicidal ideation;
   * diagnosis of and/or treatment for schizophrenia;
   * other psychotic disorders or bipolar disorder within the last 10 years;
   * current PHQ-9 score indicative of moderately severe depression;
   * severe untreated hypertension \>200/100 mmHg;
   * currently taking Wellbutrin, Zyban or bupropion;
   * hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year;
   * used pipe tobacco, cigars, snuff or chew more than twice in the past week.

It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).
B: Inclusion criteria:

* Males and females at least 18 years old.
* English speaking.
* Meets criteria for alcohol dependence or alcohol abuse.
* Must complete an alcohol detoxification program prior to entering the study.
* Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking.
* Have a current desire to stop smoking and stop drinking.
* Willing to complete followup assessments up to 12 months after treatment.
* Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use.
* One person per household.

Exclusion Criteria:

* Allergy to nicotine patch or nicotine gum.
* Weigh less than 100 pounds.
* Use other nicotine products, such as cigars, pipes or smokeless tobacco.
* Severe skin disorder.
* Active peptic ulcer.
* Active joint disease.
* Heart attack within 3 months prior to entering the study.
* Pregnant or breastfeeding female who are not on birth control.
* Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion.
* Poor vision or hearing that would interfere with using a cell phone.
* Lack of transportation to the treatment site or live at least one hour from the treatment site.
* Homeless.
C: Inclusion Criteria:

* Participant is a current smoker (≥ 10 cigarettes per day in the preceding\\ six months);
* Participant is willing to make a quit attempt in the 2-4 weeks after initial screening for eligibility;
* Participant is 18 years of age and older;
* Participant is willing to provide informed consent.

Exclusion Criteria:

* Participant is currently using or has used any intervention medications in the previous 6 months (i.e, Champix (varenicline); and/or Nicotine replacement therapy (patch, gum, inhaler, lozenge));
* Participant has contraindication(s) to any of the following smoking cessation medications:

  * Nicotine replacement therapy (allergic reaction to adhesive; serious cardiac arrhythmias (e.g., tachycardia); participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); severe or worsening angina pectoris; participant has had a recent cerebral vascular accident);
  * Varenicline (end-stage renal disease; use of cimetidine (by participants with severe renal impairment); previous allergic reaction to varenicline);
* Pregnant or breastfeeding women or those intending to become pregnant in the next year;
* Current or previous (in the last 3 months) substance abuse;
* Unable to provide informed consent due to unstable psychiatric symptoms (e.g., active, untreated psychosis or suicidality);
* Participant is unable to read and understand English or French;
* In order to prevent contamination across groups, only one person per household may participate.
D: Inclusion Criteria:

* All callers to the Colorado QuitLine who report currently smoking 16-20 cigarettes
* who enroll in QuitLine services
* who do not require physician approval to obtain nicotine replacement therapy
* who are willing to receive the nicotine patch

Exclusion Criteria:

* Contraindications to receiving the nicotine patch through the QuitLine without physician approval include: history of hearth disease (heart attack, chest pain, or coronary artery disease), high blood pressure, pregnancy, skin conditions such as difficult to manage psoriasis or eczema, or history of a local reaction to the nicotine patch
* those who do not complete the call in English

Answer: C