Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
Brief Summary: The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.


Options:
A: DISEASE CHARACTERISTICS:

* African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month

  * Not a heavy smoker
  * No other forms of tobacco within the past 30 days
* Must be interested in stopping smoking
* No other smoker in the household enrolled in this study

PATIENT CHARACTERISTICS:

* Has a home address and a functioning telephone number
* Not planning to move from the Kansas City metro area within the next 12 months
* Not pregnant or nursing
* Negative pregnancy test
* No alcohol or substance abuse within the past year
* Not currently drinking ≥ 14 alcoholic drinks per week
* No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
* No history of seizures or head trauma
* No history of bulimia or anorexia nervosa
* No myocardial infarction within the past 30 days
* No reported use of opiates, cocaine, or stimulants
* No diabetes requiring oral hypoglycemics or insulin

PRIOR CONCURRENT THERAPY:

* More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
* No other concurrent medication that contains bupropion hydrochloride
* No concurrent psychoactive medications
B: Inclusion Criteria:

* 18 years and older.
* Smoked at least 10 cigarettes/day for at least 1 year.
* English speaking.
* Females who are of childbearing potential must practice effective contraception and meet the following criteria:
* Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
* Have a negative urine pregnancy test at baseline.
* Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
* Willingness to reduce alcohol consumption during study to 2 or fewer standard drinks/day (3 oz. of alcohol or two beers (12 oz.), or two 5 oz. glasses of wine).
* Willingness to not use illicit drugs during study period including marijuana.

Exclusion Criteria:

* Concurrent use of tobacco products (other than cigarettes) or nicotine products.
* Contraindications to use of bupropion (i.e., concurrent use of other forms of bupropion, MAO inhibitors, anti-depressant medication, seizure disorder or any clinical situation that might increase risk for seizures, past head injury, current or prior diagnosis of bulimia or anorexia nervosa; bipolar disorder).
* Contraindications to use of naltrexone (i.e., past history of opioid abuse or dependence or evidence of opioid use in the past 30 days; significant hepatocellular injury as evidenced by liver enzyme levels over 3 times normal limits).
* Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
* Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
* Treatment for drug or alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol.
* Evidence of problem alcohol consumption based on AUDIT.
* Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
* Suicidal or homicidal ideation.
* Current major depression.
* History of bipolar disorder.
* Recent (within twelve months) myocardial infarction.
* Pregnant or lactating or planning pregnancy during treatment period.
* Having plans to leave the immediate geographical area within 9 months.
* Unwillingness or inability to given written informed consent.
C: 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)
D: Inclusion Criteria:Inclusion Criteria:

* Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence
* Smokes at least 10 cigarettes per day for the three months prior to enrollment
* Currently seeking treatment for nicotine dependence
* Medically healthy on the basis of physical examination and medical history, vital signs,
* Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

* DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
* Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
* History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
* Currently seeking treatment for nicotine disorders
* History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
* History of significant recent violent behavior
* Blood pressure greater than 150/90
* History of eating disorders
* History of allergic reaction to any of the study medications
* Pregnant

Answer: B