Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: A Double-Blind, Placebo-Controlled, Randomized, Trial
Brief Summary: Objectives

This protocol is intended to provide information regarding the efficacy and safety of the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation in diabetic subjects who smoke. Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at the end of the study will also be examined Study Population The study will enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking cessation. The duration of active treatment will be 12 weeks and subjects will be followed in the nontreatment phase for an additional 12 weeks. This clinical study has an optional research component to prolong the follow up in the nontreatment phase for a full year. Predictors of abstinence at the end of the study will also be examined Study Endpoints Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking in each of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44). Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at week 24 and at week 52 will also be examined


Options:
A: Inclusion Criteria:

* Age 18-75 years old
* Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
* Contemplating a smoking cessation attempt in the near future
* Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
* Able to give informed consent

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
* History of attempted suicide or expresses any current suicidal ideation
* Pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Reports desire for immediate treatment of tobacco/nicotine dependence
* Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
B: Inclusion Criteria:

* current smokers who smoke 10 or more cigarettes a day for at least one year

Exclusion Criteria:

* unstable angina
* severe cardiac arrhythmia
* recent acute myocardial infarction or cerebrovascular accident in preceding 3 months
* below 18 years old
* being pregnant or on breast-feeding
* unable to use gum
* with a previous history of failure to NRT
* with a history of hypersensitivity to nicotine
C: 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)
D: Inclusion Criteria:

1. Type 2 diabetic patients (≤ 75 years of age) who are regular smokers (≥10 cigs/day during the past year, with no period of abstinence greater than three months in the past year) and willing to quit.
2. Females of non childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception.
3. Subjects must be able to be outpatients and be assessed in a clinic setting.
4. Participating subjects must be able to provide written informed consent.

Exclusion Criteria:

1. Subjects currently or within the past 12 months requiring treatment for depression. Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder;
2. Subjects with a current or recent (within the past 12 months) history of alcoholism;
3. Subjects with a requirement to use other medications during the study that might interfere with the evaluation of the study drug (e.g., nicotine replacement therapy);
4. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using the Body Mass Index (BMI);
5. Subjects with evidence or history of clinically significant allergic (except for seasonal allergies at time of dosing), endocrine, gastrointestinal, hematological, hepatic, neurologic, pulmonary, or renal disease or a history of cancer (excluding treated basal cell carcinoma and squamous cell carcinoma). Exceptions to this exclusion may include subjects with a history of mild chronic obstructive pulmonary disease, and stable thyroid disease.
6. Subjects with a history of clinically significant cardiovascular disease. In addition, subjects with uncontrolled hypertension or a screening or baseline systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg will be excluded.

Answer: D