Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: Inclusion Criteria:

1. Age 18-65, male or female
2. Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
3. Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
4. Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
5. Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
6. Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
7. Reports not quitting smoking in the past three months for more than one week duration
8. Agrees to attend behavioral counseling sessions and complete study measures
9. Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend

Exclusion Criteria:

1. Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
2. Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
3. Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
4. Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
5. Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
6. History of adverse reaction to opioid antagonist or nicotine replacement treatment
7. Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
8. Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
9. Unwillingness to agree to DNA analysis.
B: Inclusion Criteria:

* HIV-infected patients
* adults
* regular smokers (at least 10 cigarettes a day during the last year)
* motivated to stop smoking
* followed in one of the participating clinical ward,
* signed written inform consent

Exclusion Criteria:

* current co-dependency to another psychoactive substance
* ongoing depressive episode
* history of suicidal attempt
* ongoing treatment by interferon
* treatment by efavirenz for less than three months or not tolerated
* previous use of varenicline
* ongoing treatment by bupropion-SR or nicotinic substitute
* ongoing pregnancy
* ongoing breastfeeding
* hypersensitivity to varenicline or to one of its excipients
* drivers, air traffic controller
C: Inclusion Criteria:

1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.
2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.
3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.

Exclusion Criteria:

1. Women who are pregnant, planning a pregnancy, or lactating.
2. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.
3. Current treatment of cancer or diagnosed with cancer in the past 6 months
4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).
5. Current use of TN or other forms of NRT.
6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).
D: Inclusion Criteria:

1. Males or females aged 18-65 years, inclusive
2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
3. Able to give signed informed consent
4. Eligible female patients will be:

   1. non-pregnant
   2. non-lactating
   3. agree to use an acceptable method of effective contraception during the study
5. Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
6. Body weight of ≥50 kg (110 pounds), inclusive
7. Considered to be in stable health in the opinion of the investigator

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Prior or current use of lorcaserin HCl
2. Prior participation in any study of a nicotine vaccination
3. Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
4. Use of tobacco products other than cigarettes
5. Prior use of fenfluramine or dexfenfluramine
6. Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
7. Previous participation in any clinical study within 6 weeks prior to the screening visit
8. History of severe allergies, severe drug or excipient allergy or hypersensitivity
9. History of significant cardiovascular condition
10. History of other significant medical conditions
11. Significant risk of suicide
12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
14. Recent history of alcohol or drug/solvent abuse
15. Concurrent participation in the study by more than one member of the same household
16. Not suitable to participate in the study in the opinion of the investigator

Answer: C