A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol.

Reducing exposure to cigarette smoke is an imperative for public health and for diabetic patients. Patients with diabetes who continue to smoke face challenges at quitting and the delivery of effective smoking cessation interventions is a major unmet need. The high-affinity α4ß2 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited. A clinical trial of varenicline targeted specifically at smokers with T2DM is warranted. This randomized, double blind, placebo-controlled trial will be the first study to test efficacy and safety of varenicline in smokers with type 2 diabetes mellitus (T2DM) over the course of 52 weeks. We hypothesize that varenicline treatment (1 mg BID, administered for 12 weeks) would increase quit rates, maintain smoking abstinence up to 1 year after treatment, and be well-tolerated in T2DM smokers intending to quit. Efficacy end points will include carbon monoxide-confirmed continuous abstinence rate (CAR) and 7-day point prevalence of abstinence. The results of this RCT will help inform medical/health authorities and physicians worldwide whether an optimally varenicline-treated cohort of T2DM patients who smoke will experience significant success rates, without significant side effects.Trial registration NCT01387425 ( https://clinicaltrials.gov/ct2/show/NCT01387425 ).

Sensory experiences and cues among E-cigarette users.

BACKGROUND AND AIMS: We characterized the extent and quality of respiratory sensations and sensory-related smoking cues associated with e-cigarette use among those who failed to quit combustible tobacco cigarette (CTC) use with traditional FDA approved medications but succeeded in doing so with e-cigarettes. Further, we sought to understand former smokers' perceptions about the influence of sensory experience with e-cigarette use on CTC cessation outcomes. METHODS: A nonrandom purposive sample of 156 participants recruited in the USA through the Consumer Advocates for Smoke Free Alternatives Association Facebook page completed an online cross-sectional survey to assess sensory experiences and smoking cues associated with e-cigarette use. Descriptive statistics were calculated, and the ANOVA/Kruskal-Wallis test with post hoc testing and the two-sample t test/Wilcoxon rank-sum test, as appropriate based on distribution, were used to assess the association between sample characteristics and sensory experiences and cues using investigator constructed questions, the Modified Cigarette Evaluation Questionnaire (mCEQ) and the Smoking Cue Appeal Survey (SCAS). RESULTS: With e-cigarette use, participants reported feeling the vapor in their throats, windpipes, noses, lungs, and on their tongues; reductions in nicotine craving; and enjoyment of their e-cigarette, including tasting, smelling, and seeing the vapor and touching the device. Women had greater craving reduction than men (p = 0.023). Those who began smoking at 13 years of age or younger had more satisfaction and had greater sensory enjoyment than those who began smoking at 16-17 years of age (p = 0.015 and p = 0.026, respectively), as well as greater sensory enjoyment than those who began smoking at 14-15 years of age (p = 0.047). There was a significant overall association between the number of years a respondent smoked and e-cigarette sensory enjoyment (p = 0.038). Participants 18-34 years old rated e-cigarettes as being more pleasant compared to 45 + years olds, (p = 0.012). Eighty-four percent of participants reported the sensation of the vapor as important in quitting CTCs, and 91% believed the sensations accompanying e-cigarette use contributed to their smoking cessation success. CONCLUSIONS: For those who failed to quit previously using approved cessation medications to stop smoking cigarettes, sensory experiences associated with e-cigarette use may help smokers quit smoking.