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"WEEKS, GREGORY"
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The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial
IntroductionSmoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.AimsTo evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.Methods and analysisThis is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.Ethics and disseminationThe trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.Trial registration numberAustralia New Zealand Clinical Trials Registry (ACTRN12618001792213).
Journal Article
Development and validation of a 21-item challenges to stopping smoking (CSS-21) scale
ObjectiveIdentification of challenges associated with quitting and overcoming them may improve cessation outcomes. This study describes the development and initial validation of a scale for measuring challenges to stopping smoking.MethodsThe item pool was generated from empirical and theoretical literature and existing scales, expert opinion and interviews with smokers and ex-smokers. The questionnaire was administered to smokers and recent quitters who participated in a hospital-based smoking cessation trial. Exploratory factor analysis was performed to identify subscales in the questionnaire. Internal consistency, validity and robustness of the subscales were evaluated.ResultsOf a total of 182 participants with a mean age of 55 years (SD 12.8), 128 (70.3%) were current smokers and 54 (29.7%) ex-smokers. Factor analysis of the 21-item questionnaire resulted in a 2-factor solution representing items measuring intrinsic (9 items) and extrinsic (12 items) challenges. This structure was stable in various analyses and the 2 factors accounted for 50.7% of the total variance of the polychoric correlations between the items. Internal consistency (Cronbach's α) coefficients for the intrinsic and extrinsic subscales were 0.86 and 0.82, respectively. Compared with ex-smokers, current smokers had a higher mean score (±SD) for intrinsic (24.0±6.4 vs 20.5±7.4, p=0.002) and extrinsic subscales (22.3±7.5 vs 18.6±6.0, p=0.001).ConclusionsInitial evaluation suggests that the 21-item challenges to stopping smoking scale is a valid and reliable instrument that can be used in research and clinical settings to assess challenges to stopping smoking.
Journal Article
Reaching for Autonomy: U.S.-Latin American Relations in the Trump Era
During his term in office, Donald Trump was consistently hostile toward Latin America and its people. Regardless of what they felt about him, Latin American leaders had no choice but to adapt to an era of confrontation and unpredictability. This paper uses the concept of autonomy to make a twofold argument. First, Trump accelerated an already existing trend whereby Latin American leaders increasingly looked to expand opportunities of all kinds with governments outside the hemisphere. Second, ideological and nationalist obstacles within Latin America slowed or even blocked autonomous action. Trump held open the autonomy door, so to speak, but many were hesitant to walk through it. Key Words: Donald Trump, U.S.-Latin American Relations, Autonomy, Realist Theory, Dependency Theory
Journal Article
Quitting experiences and preferences for a future quit attempt: a study among inpatient smokers
Objective Understanding smokers’ quit experiences and their preferences for a future quit attempt may aid in the development of effective cessation treatments. The aims of this study were to measure tobacco use behaviour; previous quit attempts and outcomes; methods used to assist quitting; difficulties experienced during previous attempts; the motives and preferred methods to assist quitting in a future attempt; identify the factors associated with preferences for smoking cessation. Design Face-to-face interview using a structured questionnaire. Setting Inpatient wards of three Australian public hospitals. Participants Hospitalised smokers enrolled in a smoking cessation trial. Results Of 600 enrolled patients (42.8% participation rate), 64.3% (n=386) had attempted quitting in the previous 12 months. On a scale of 1 (low) to 10 (high), current motivation to quit smoking was high (median 9; IQR 6.5–10), but confidence was modest (median 5; IQR 3–8). Among 386 participants who reported past quit attempts, 69.9% (n=270) had used at least one cessation aid to assist quitting. Nicotine replacement therapy (NRT) was most commonly stated (222, 57.5%), although the majority had used NRT for <4 weeks. Hypnotherapy was the most common (68, 17.6%) non-pharmacological treatment. Over 80% (n=311) experienced withdrawal symptoms; craving and irritability were commonly reported. Most participants (351, 58.5%) believed medications, especially NRT (322, 53.7%), would assist them to quit in the future. History of previous smoking cessation medication use was the only independent predictor of interest in using medications for a future quit attempt. Conclusions The majority of smokers had attempted quitting in the previous 12 months; NRT was a popular cessation treatment, although it was not used as recommended by most. This suggests a need for assistance in the selection and optimal use of cessation aids for hospitalised smokers. Trial registration number Australian and New Zealand Clinical Trials Registry: ACTRN12612000368831.
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