Please select the eligibility criteria that correspond to the clinical trial below.
Title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Brief Summary: Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.


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:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
C: 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.
D: Inclusion Criteria:

* Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

Exclusion Criteria:

* History of myocardial infarction in the preceding 3 months
* Pregnancy or breast-feeding
* Use of any form of smokeless tobacco or other nicotine replacement therapy

Answer: D