Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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