Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Brief Summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.


Options:
A: INCLUSION CRITERIA

* Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
* Interested in quitting smoking

  * Willing to set a quit date 7 days after baseline assessment
* Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

  * Codac, Inc. (with two independent sites)
  * Addiction Recovery Institute
  * Center for Treatment and Recovery
  * Discovery House
* Has received methadone for at least the past month

EXCLUSION CRITERIA

* Pregnant or nursing (Must have negative pregnancy test)
* Non-English speaking
* No personal telephone or does not live close to a relative or neighbor with a telephone
* Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
* Unvailable for this study for the next 12 months
* Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
* Active skin condition (e.g., psoriasis)
* History of skin allergy
* History of a suicide attempt
* Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent insulin or blood thinners
* No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
B: Inclusion Criteria:

* Veteran status
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
* Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
* Be willing to make an attempt to quit smoking in the next 30 days
* Be capable of providing informed consent
* Have access to a telephone (land line or cell phone)
* Have a stable residence

Exclusion Criteria:

* Planning to move within the next 12 months
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized
C: Inclusion Criteria:

* Subjects must have smoked an average of at least 15 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular disease in the past 6 months.
D: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
* Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
* Smokes at least 20 cigarettes per day (1 pack per day)
* Expired breath CO level \> 10 ppm and cotinine level \> 210 ng/ml at the baseline measurement
* Currently taking a stable dose of antipsychotic
* Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation

Exclusion Criteria:

* Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
* History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
* Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
* Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
* Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
* History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

Answer: C