Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Brief Summary: Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop and evaluate a stepped-care treatment algorithm that would evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or switched to Chantix only based on: 1) their initial response to NRT; and 2) individual genetic factors found to predict smoking cessation in other studies evaluating these treatments. This study is a continuation of our previous studies showing that abstinence rates can be increased by starting nicotine patch therapy two weeks before the quit date. The investigators will provide pre-cessation NRT to all participants initially. Those who do not show a favorable response on early indicators of success (e.g., smoking in the first week after the target quit-smoking date) will receive "rescue" treatment by having their NRT treatment supplemented with Zyban , by being switched to treatment with Chantix or will remain on NRT (control).

The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or Chantix will increase success rates over leaving subjects on NRT when they are NRT insufficient responders, i.e. they have shown an unfavorable response to NRT in the first week pre-quit or the first week post-quit.


Options:
A: Inclusion Criteria:

* Inclusion Criteria are:

  1. DSM-IV diagnosis of Schizophrenia or schizoaffective disorder
  2. Age: 18-64
  3. Regular half pack a day smokers
  4. Score of at least 4 on the Nicotine Dependency Test

     Exclusion Criteria:

     Exclusion Criteria are:

  <!-- -->

  1. Seizure disorders, other Neurologic illnesses, or a family history of seizures
  2. A medical condition that could manifest psychiatrically
  3. Currently experiencing a depressive episode
  4. Active substance abuse
  5. Currently receiving bupropion
  6. Pregnant women
  7. Children (\<18 years of age)
  8. Two consecutive sodium levels of 130 mmol/L or less
B: Inclusion Criteria:

* 18-65 years old
* smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
* expired carbon monoxide reading of at least 15ppm
* express a desire to quit smoking in the next 30 days

Exclusion Criteria:

* Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
* Hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg).
* Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and 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, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
* 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;
* Lung disorder (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);
* History of migraine headaches in the past 5 years;
* History of fainting;
* 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 - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score \>9 (or who score \>0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
* Bulimia or anorexia;
* Pregnant or nursing mothers;
* Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
* Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
* Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
* Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse. Potential participants will be asked the first two questions on the AUDIT questionnaire during the phone screen. If the person scores "4" on both questions, a screening appointment will not be scheduled. During the screening session the entire AUDIT questionnaire will be administered. Females who score greater than or equal to 13 and males who score greater than or equal to 15 will be excluded from the study.
* Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the past
C: Inclusion Criteria:

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

Exclusion Criteria:

* Subjects with any history of cardiovascular disease
* Myocardial infarction
* Significant arrhythmias
* Poorly controlled hypertension
D: Inclusion Criteria:

* Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope.
* Have a diagnosis of alcohol abuse or alcohol dependence.
* Smoke 20 or more cigarettes/day (may also smoke pipes/cigars).
* Be interested in quitting smoking.
* Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period.
* If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study.
* Agree to sign informed consent.
* Able to read and understand study-related forms and procedures.

Exclusion Criteria:

* Advanced cardiac, pulmonary, renal, or liver disease.
* History of seizures.
* History of brain tumor or significant head trauma.
* History of bulimia or anorexia nervosa.
* Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder.
* Using psychoactive drugs.
* Receiving treatment with medications that lower seizure thresholds.
* Use of an investigational drug in any study in the past four weeks.
* Currently using any asthma medication.
* Used time-released bupropion in the past 12 months.
* Currently using any other treatments to stop smoking.

Answer: B