Please select the arm or intervention descriptions that belong 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: Arm Label: High Intensity Counseling + Long Acting NRT + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + Long Acting NRT + PRN NRT | Arm Label: High Intensity Counseling + bupropion + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + bupropion + PRN NRT | Arm Label: High Intensity Counseling + varenicline + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + varenicline + PRN NRT | Arm Label: High Intensity Counseling + Long Acting NRT; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + Long Acting NRT | Arm Label: High Intensity Counseling + bupropion; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + bupropion | Arm Label: High Intensity Counseling + varenicline; Type: EXPERIMENTAL; Interventions: Drug: High Intensity Counseling + varenicline | Arm Label: Low Intensity Counseling + Long Acting NRT + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + Long Acting NRT + PRN NRT | Arm Label: Low Intensity Counseling + bupropion + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + bupropion + PRN NRT | Arm Label: Low Intensity Counseling + varenicline + PRN NRT; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + varenicline + PRN NRT | Arm Label: Low Intensity Counseling + Long Acting NRT; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + Long Acting NRT | Arm Label: Low Intensity Counseling + bupropion; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + bupropion | Arm Label: Low Intensity Counseling + varenicline; Type: EXPERIMENTAL; Interventions: Drug: Low Intensity Counseling + varenicline | Intervention Type: DRUG; Name: High Intensity Counseling + Long Acting NRT + PRN NRT; Assigned to Arm(s): High Intensity Counseling + Long Acting NRT + PRN NRT | Intervention Type: DRUG; Name: High Intensity Counseling + bupropion + PRN NRT; Assigned to Arm(s): High Intensity Counseling + bupropion + PRN NRT | Intervention Type: DRUG; Name: High Intensity Counseling + varenicline + PRN NRT; Assigned to Arm(s): High Intensity Counseling + varenicline + PRN NRT | Intervention Type: DRUG; Name: High Intensity Counseling + Long Acting NRT; Assigned to Arm(s): High Intensity Counseling + Long Acting NRT | Intervention Type: DRUG; Name: High Intensity Counseling + bupropion; Assigned to Arm(s): High Intensity Counseling + bupropion | Intervention Type: DRUG; Name: High Intensity Counseling + varenicline; Assigned to Arm(s): High Intensity Counseling + varenicline | Intervention Type: DRUG; Name: Low Intensity Counseling + Long Acting NRT + PRN NRT; Assigned to Arm(s): Low Intensity Counseling + Long Acting NRT + PRN NRT | Intervention Type: DRUG; Name: Low Intensity Counseling + bupropion + PRN NRT; Assigned to Arm(s): Low Intensity Counseling + bupropion + PRN NRT | Intervention Type: DRUG; Name: Low Intensity Counseling + varenicline + PRN NRT; Assigned to Arm(s): Low Intensity Counseling + varenicline + PRN NRT | Intervention Type: DRUG; Name: Low Intensity Counseling + Long Acting NRT; Assigned to Arm(s): Low Intensity Counseling + Long Acting NRT | Intervention Type: DRUG; Name: Low Intensity Counseling + bupropion; Assigned to Arm(s): Low Intensity Counseling + bupropion | Intervention Type: DRUG; Name: Low Intensity Counseling + varenicline; Assigned to Arm(s): Low Intensity Counseling + varenicline
B: Arm Label: Placebo Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Smoking cessation counseling, Drug: Placebo | Arm Label: Experimental: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Smoking cessation counseling, Drug: Varenicline | Intervention Type: BEHAVIORAL; Name: Smoking cessation counseling; Assigned to Arm(s): Experimental: Varenicline, Placebo Control | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Control | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Experimental: Varenicline
C: Arm Label: Control (Usual care); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Tobacco Cessation Tool (CATI Tool); Type: EXPERIMENTAL; Interventions: Behavioral: CATI Tool | Intervention Type: BEHAVIORAL; Name: CATI Tool; Assigned to Arm(s): Tobacco Cessation Tool (CATI Tool)
D: Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: varenicline | Arm Label: control group; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo tablet is made of lactose | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo tablet is made of lactose; Assigned to Arm(s): control group

Answer: D