Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


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:

* Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) \>10 ppm at screening.
* Subjects with mild to moderate depression or anxiety may be included if their condition is stable.

Exclusion Criteria:

* Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
* Subjects with severe depression or anxiety.
* Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
* Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
C: Inclusion Criteria:

* Male or female subjects, 18-75 years old
* Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
* Smoking at least 10 cigarettes per day
* Weight of at least 100 lbs (45.4 kg)
* Motivation to quit smoking
* Stabilized psychotic symptoms
* Provision of informed consent for testing and treatment

Exclusion Criteria:

* Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
* Seizure disorder, recent withdrawal from alcohol or anxiolytics
* History of bulimia nervosa, anorexia nervosa, or dementia
* History of depression, panic, or bipolar disorders
* Pregnancy or lactation
* Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
* Current use of other smoking cessation treatments
* Regular use of non-cigarette tobacco products (\> than once/week)
* Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
* Patients with suicidal ideations or plans
* Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
* History of, or current, alcohol dependence/abuse
* Current use of monoamine oxidase inhibitors (MAOI)
D: Inclusion Criteria:

* Smokes at least 10 cigarettes per day for at least the past 2 years
* Meets DSM-IV criteria for nicotine dependence, as determined by the Fagerstrom Nicotine Tolerance Questionnaire
* Meets DSM-IV diagnoses of unipolar depressive disorders (major depression, dysthymia, and minor depression)

Exclusion Criteria:

* Current suicidal or homicidal risk
* Serious illness, including cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or hematologic disease
* Untreated peptic ulcer
* Life-threatening arrhythmia, cerebrovascular, or cardiovascular event within the 6 months prior to enrollment
* Severe respiratory compromise, as defined as a FEV-1 less than 1.0 L/min and/or pO2 less than 60 or pCO2 less than 45
* Currently using nicotine-containing products (e.g., cigar, pipe, snuff, nicotine gum)
* History of a seizure disorder
* Current DSM-IV diagnosis of organic mental disorder, schizophrenia, delusional disorder, psychotic disorder, bipolar disorder, or antisocial personality disorder
* Current DSM-IV diagnosis of substance abuse or dependence disorders within the year prior to enrollment
* Current eating disorder, including anorexia nervosa and bulimia nervosa
* History of multiple adverse drug reactions or allergy to bupropion
* Mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs (with the exception of hypnotics and benzodiazepines at stable doses for at least six months prior to enrollment or current use of nonbenzodiazepine hypnotics such as Ambien and Sonata)
* Clinical or laboratory evidence of hypothyroidism
* Currently seeking treatment for smoking cessation
* History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, or tapes
* Currently using topical drugs
* Pregnant
* Not using adequate methods of contraception

Answer: D