Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Brief Summary: The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019


Options:
A: Inclusion Criteria:

* Subjects must have smoked an average of at least ten cigarettes per day during the past year
* No period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with history of clinically significant cardiovascular disease
* Subjects with uncontrolled hypertension.
B: Inclusion Criteria:

* Have no known serious medical conditions;
* Male;
* Are 18-65 years old;
* Smoke an average of at least 10 cigarettes per day;
* Have smoked at least one cumulative year;
* Have an expired air carbon monoxide (CO) reading of at least 10ppm;
* Able to read and understand English;
* Express a desire to quit smoking in the next thirty days.

Potential subjects must agree to use acceptable contraception.

Potential subjects must agree to avoid the following:

* participation in any other nicotine-related modification strategy outside of this protocol;
* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
* use of experimental (investigational) drugs or devices;
* use of illegal drugs;
* use of opiate medications.

Exclusion Criteria:

* Hypertension;
* Hypotension with symptoms;
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years;
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
* Smoking more than one cigar a month.
* Alcohol abuse;
* Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.
* Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.
* Current participation in another research study.

Use (within the past 30 days) of:

* Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.
C: Inclusion Criteria:

* Age 18-60
* DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment
* Sufficient understanding of the study and risks (ESC score 10 or above)

Exclusion Criteria:

* Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
* History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
* DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana
* On nicotine replacement therapy (nicotine patch, gum, or nasal spray)
* Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)
* EKG of second or third degree atrioventricular (AV) block
* Renal insufficiency with estimated creatinine clearance \<40 ml/min
* Women who have positive urine pregnancy tests
* Women who are pregnant, plan to become pregnant, or in breastfeeding
D: 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

Answer: A