Please select the eligibility criteria that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Inclusion Criteria:

1. Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
2. Baseline urine cotinine level greater than 100 ng/ml.
3. Age range of 12 - 21
4. If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
5. For post menarchal female participants: agree to use birth control to avoid pregnancy.

Exclusion Criteria:

1. Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
2. Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
3. Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
4. Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
5. History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
6. History of severe renal, hepatic, neurological, or chronic pulmonary disease. This criterion was chosen due to the hepatic metabolism of bupropion.
7. Unstable medical problems
8. Allergy to bupropion
9. Current treatment with any other medication containing bupropion
10. Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2 weeks of starting the study since there may be serious and severe medical interactions between MAO inhibitors and bupropion SR.
11. Current treatment with nicotine replacement therapy (NRT)
12. History of intolerance or non-response to bupropion SR.
13. Current (past month) suicide ideation
14. Suicide attempt (past year)
B: Inclusion Criteria:

* Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria:

* Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
* Any subject with known severe chronic obstructive pulmonary disease (COPD)
C: Inclusion Criteria:

* Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
* Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
* Current DSM-IV diagnosis of Nicotine Dependence
* Current DSM-IV diagnosis of Alcohol Dependence
* Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
* An average of at least one pack of cigarettes per day (\>=20 cigarettes/day) over the 7 days prior to intake
* An average of at least 7 drinks over the 7 days prior to intake

Exclusion Criteria:

* Inability to give adequate informed consent
* Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
* Currently taking naltrexone (ReVia), Campral or Antabuse
* Participation in a clinical trial less than 3 months prior to intake
* History of suicide attempt in the past year
* History of hospitalization due to suicidal ideation in the past year
* Suicidal ideation at baseline
* Known allergic reaction to varenicline
* Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.
* Female patients who are pregnant or nursing.
* Significant unstable medical problems (e.g. impaired renal function).
* Significant unstable psychiatric disorders.
* Subjects who do not attend all required screening appointments.
* Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
* Positive urine drug screen for cocaine, opioids or amphetamine at baseline
* Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)
* Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)
* Weight over 250 lbs
* Claustrophobia
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: D