Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Naltrexone in Women's Smoking Cessation
Brief Summary: The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling.

Hypotheses:

1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
3. These effects are predicted to be stronger in women compared to men.


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:

* Current male or female cigarette smokers who are motivated to stop smoking.
* Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

* Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
* Patients currently with depression or diagnosed with depression in past 12 months.
* Past or present history of psychosis, panic disorder, or bipolar disorder.
C: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant, recent cardiovascular disease.
D: Inclusion Criteria:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)

Answer: A