varenicline 1 mg BID. The duration of active treatment will be 12 weeks.

Smoking Cessation

Diabetes

varenicline at a dose of 1 mg twice a day for 12 week

varenicline

placebo at a dose of 1 mg twice for 12 week

placebo tablet is made of lactose

Centro per la Prevenzione e Cura del Tabagimso

Centro per la Prevenzione eCura del Tabagimso

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: A Double-Blind, Placebo-Controlled, Randomized, Trial

Adverse events observed or reported will be recorded. Assessments as to seriousness, severity, and the relationship to treatment and other causes will be made. Physical examination will be performed at the screening visit and at Wk 12. Blood pressure and heart rate will be measured at all visits. BMI and waist will be calculated at the screening visit and at Week 13, 24, 52. Blood chemistry, complete blood count, and urinalysis will be completed at screening, baseline, Week 2 and 12.

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 (NUI) 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.

Express the percentage of participants with Adverse Events in the active and in the placebo group.

This measures the % change from baseline. An improvement in systolic blood pressure is anticipated.

This measures the % change from baseline. An improvement in HbA1c is anticipated

This measures the % change from baseline. An slight increase in BMI is expected in the first few months after cessation.

Riccardo Polosa

Professor of Internal Medicine

Universita degli Studi di Catania

Please see the Study Description for complete information.

Immunodeficiency

St. Jude Children's Research Hospital

Peripheral Blood Stem Cells Obtained From Normal Volunteers for Studying Retroviral Vector Mediated Gene Transfer Into Primitive Hematopoietic Cells and Vector Mediated Transgene Expression in Mature Hematopoietic Lineages

thrombophilia/phosphatase

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)

Peripheral Blood Stem Cells Obtained From Normal Volunteers for Studying Retroviral Vector Mediated Gene Transfer Into Primitive Hematopoietic Cells and Vector Mediated Transgene Expression in Mature Hematopoietic Lineages

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