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Varenicline has shown promise for treating alcohol use disorder (AUD); however, not everyone will respond to varenicline. Machine-learning methods are well suited to identify treatment responders. In the present study, we examined data from the National Institute on Alcohol Abuse and Alcoholism Clinical Intervention Group multisite clinical trial of varenicline using two machine-learning methods. Baseline characteristics taken from a randomized clinical trial of varenicline were examined as potential moderators of treatment response using qualitative interaction trees (N = 199) and group least absolute shrinkage and selection operator interaction nets (N = 200). Results align with prior research, highlighting smoking status, AUD severity, medication adherence, and drinking goal as predictors of treatment response. Novel findings included the interaction between age and cardiovascular health in predicting clinical response and stronger medication effects among individuals with lower craving. With increased integration of machine-learning methods, studies that effectively integrate methods and medication development have high potential to inform clinical practice.

Background: Smoking cessation is crucial for reducing complications of type 2 diabetes mellitus (T2DM), but associated weight gain can worsen glycemic control, discouraging quitting attempts. Varenicline, a partial agonist of α4β2 nicotinic receptors, aids smoking cessation. This study examines the effects of varenicline on body weight and metabolic parameters in patients with T2DM and prediabetes. Methods: Fifty-three patients were enrolled, of which 32 successfully quit smoking after a three-month course of varenicline and were examined after an additional month with no medication. Measurements taken at baseline, 2.5 months, and 4 months included body weight, blood pressure, resting metabolic rate (RMR), glycated hemoglobin (HbA1c), fasting glucose, blood lipids, C-reactive protein (CRP), appetite-related hormones, and physical activity. Results: Post-treatment, there were no significant changes in body weight, blood pressure, RMR, or glycemic control. Total (CHOL) and low-density lipoprotein (LDL-C) cholesterol decreased significantly at 4 months of the study (from 168 to 156 mg/dL, p = 0.013, and from 96 to 83 mg/dL, p = 0.013, respectively). Leptin levels increased (from 11 to 13.8 ng/dL, p = 0.004), as did glucagon-like peptide-1 (GLP-1) levels (from 39.6 to 45.8 pM, p = 0.016) at 4 months of follow-up. The percentage of participants who reported moderate-intensity activity increased from 28% to 56%, while those reporting high-intensity activity increased from 19% to 22%, respectively (p = 0.039). Conclusions: Our study showed that smoking cessation with varenicline in smokers with T2DM and prediabetes led to significant improvements in lipid profile, significant increase in plasma leptin and GLP-1 levels, and increased physical activity, without significant weight gain. Thus, smoking cessation without weight gain or deteriorated glycemic control is feasible for these smokers, with added benefits to lipid profiles, GLP-1 regulation, and physical activity. [ABSTRACT FROM AUTHOR]

Background and aims: Varenicline is one of the most effective smoking cessation treatments. Its supply in England was disrupted in July 2021 due to nitrosamine impurities found by its supplier, Pfizer. This study measured the impact of this disruption on smoking cessation in England. Design, setting and participants: The study used repeated cross‐sectional surveys conducted monthly, from June 2018 to December 2022. Set in England, it comprised a total of 3024 adults who reported smoking during the past year and had made at least one serious attempt to quit in the past 6 months. Measurements: Generalized additive models analyzed the association of the varenicline supply disruption with the trend in self‐reported varenicline use in the most recent quit attempt. We used these results to estimate the population‐level impact of the disruption on smoking cessation. Findings Before July 2021, the proportion of past 6‐month quit attempts using varenicline was stable at approximately 3.9% [risk ratio (RR)trend = 1.034, 95% confidence interval (CI) = 0.823–1.298]. The trend in varenicline use has changed sharply since the supply disruption (RRΔtrend = 0.297, 95% CI = 0.120–0.738), with prevalence falling by 69.3% per year since; from 4.1% in June 2021 to 0.8% in December 2022. Convergently, National Health Service general practitioner prescribing data reported that just 0.1% of prescriptions for smoking cessation treatments in December 2022 were for varenicline. Assuming that varenicline does not return to the market, we estimate that this could result in ~8400 fewer people stopping smoking for at least 6 months, ~4200 fewer long‐term ex‐smokers and ~1890 more avoidable deaths each year. Conclusions: In England, the disruption in supply of varenicline since 2021 has coincided with a substantial fall in the use of varenicline in attempts to quit smoking. [ABSTRACT FROM AUTHOR]

Aims: To conduct a systematic review and meta‐analysis and pool the incremental net benefits (INBs) of varenicline compared with behaviour support with bupropion or nicotine replacement therapy (NRT), behaviour support alone and unaided cessation in adult smokers making a first‐time attempt to quit. Methods: A search for economic evaluation studies was conducted from inception to 30 September 2022, on PubMed, Embase, Cost‐Effectiveness Analysis (CEA) Registry by Tufts Medical Centre, EconLit and the NHS Economic Evaluation Database (NHS EED). Eligible studies were included if they were (1) conducted among adults ages 18 years old and older who were smokers attempting to quit for the first time; (2) compared varenicline to behaviour support with bupropion or NRT, behaviour support alone and unaided cessation; and (3) performed a CEA or cost‐utility analysis. The INBs were calculated and pooled across studies stratified by country income level and study perspective using the random‐effects model. Statistical heterogeneity between studies was assessed using the I2 statistic and Cochrane Q statistic. Results: Of the 1433 identified studies, 18 studies were included in our review. Our findings from healthcare system/payer perspective suggested that the use of varenicline is statistically significantly cost‐effective compared with bupropion (pooled INB, $830.75 [95% confidence interval, $208.23, $1453.28]), NRTs ($636.16 [$192.48, $1079.84]) and unaided cessation ($4212.35 [$1755.79, $6668.92]) in high‐income countries. Similarly, varenicline is also found to be cost‐effective compared to bupropion ($2706.27 [$1284.44, $4128.11]), NRTs ($3310.01 [$1781.53, $4838.50]) and behavioural support alone ($5438.22 [$4105.99, $6770.46]) in low‐ and middle‐income countries. Conclusion: Varenicline is cost‐effective as a smoking cessation aid when compared with behavioural support with bupropion or nicotine replacement therapies and behavioural support alone in both high‐income countries and low‐ and middle‐income countries, from the healthcare system/payer perspective in adult smokers who attempt to quit for the first time. [ABSTRACT FROM AUTHOR]

Introduction: tobacco is one of the main causes of preventable mortality in our environment, in addition to having been correlated with numerous diseases. Smoking cessation improves health status and life expectancy. Pharmacological treatment of smoking cessation increases the likelihood that patient will successfully quit smoking. Method and design: a search was carried out in the PubMed and UpToDate databases, obtaining a total of 11 systematic reviews or meta-analyses published in the last five years. After applying inclusion criteria and reading summaries, 5 total articles were obtained for the final review. Results and discussion: Cytisine is a safe and effective treatment for smoking cessation. The most effective treatment in the clinical trials reviewed is varenicline associated with nicotine replacement therapy. There is less evidence collected on cytisine treatment, but it shows that it is also an effective therapy in smoking cessation, also demonstrating its usefulness in the long term. In addition, therapy with cytisine seems to entail fewer adverse effects than treatment with varenicline. [ABSTRACT FROM AUTHOR]

Introduction This study aims to clarify differences in mood, craving, and treatment response between reward and relief/habit individuals in a study of naltrexone, varenicline, and placebo. We hypothesized that relief/habit individuals would have a poorer mood during early abstinence and higher levels of alcohol craving than reward individuals. We hypothesized that reward individuals would demonstrate better drinking outcomes on naltrexone versus placebo. Methods Data were culled from a randomized, double-blind, placebo-controlled human trial of 53 individuals (18F/16M) with alcohol use disorder randomized to varenicline (n  = 19), naltrexone (n  = 15), or matched placebo (n  = 19). In this 6-day practice quit trial, participants attempted to abstain from drinking and completed daily diaries. Participants were classified into reward or relief/habit subgroups based on self-reported motivation for drinking. Multilinear models tested differences in mood and alcohol craving between reward and relief/habit individuals. General linear models tested differences between reward and relief/habit individuals' drinking outcomes on each medication versus placebo. Results Relief/habit individuals showed decreases in positive mood and increases in negative mood over the quit attempt across medications, compared to reward individuals (P 's < .05). Reward individuals' tension decreased on naltrexone, while relief/habit individuals' tension remained stable (F  = 3.64, P  = .03). Reward individuals in the placebo group had higher percent days abstinent than relief individuals in the placebo group (P  < .001). Discussion This study suggests relief/habit individuals' mood worsens during early abstinence. Our finding that reward individuals' tension decreased on naltrexone and increased on placebo may suggest a clinical response to the medication. [ABSTRACT FROM AUTHOR]

Abstract Background With expanded and sustained availability of HIV treatment resulting in substantial improvements in life expectancy, the need to address modifiable risk factors associated with leading causes of death among people living with HIV/AIDS (PLWH), such as tobacco smoking, has increased. Tobacco use is highly prevalent among PLWH, especially in southern Africa, where HIV is heavily concentrated, and many people who smoke would like to quit but are unable to do so without assistance. SBIRT (Screening, Brief Intervention and Referral to Treatment) is a well-established evidence-based approach successful at supporting smoking cessation in a variety of settings. Varenicline is efficacious in supporting smoking cessation. We intend to assess the effectiveness of SBIRT and varenicline on smoking cessation among PLWH in Botswana and the effectiveness of our implementation. Methods BSMART (Botswana Smoking Abstinence Reinforcement Trial) is a stepped-wedge, cluster randomized, hybrid Type 2 effectiveness-implementation study guided by the RE-AIM framework, to evaluate the effectiveness and implementation of an SBIRT intervention consisting of the 5As compared to an enhanced standard of care. SBIRT will be delivered by trained lay health workers (LHWs), followed by referral to treatment with varenicline prescribed and monitored by trained nurse prescribers in a network of outpatient HIV care facilities. Seven hundred and fifty people living with HIV who smoke daily and have been receiving HIV care and treatment at one of 15 health facilities will be recruited if they are up to 18 years of age and willing to provide informed consent to participate in the study. Discussion BSMART tests a scalable approach to achieve and sustain smoking abstinence implemented in a sustainable way. Integrating an evidence-based approach such as SBIRT, into an HIV care system presents an important opportunity to establish and evaluate a modifiable cancer prevention strategy in a middle-income country (MIC) setting where both LHW and non-physician clinicians are widely used. The findings, including the preliminary cost-effectiveness, will provide evidence to guide the Botswanan government and similar countries as they strive to provide affordable smoking cessation support at scale. Clinical trial registration NCT05694637 Registered on 7 December 2022 on clinicaltrials.gov, https://clinicaltrials.gov/search?locStr=Botswana&country=Botswana&cond=Smoking%20Cessation&intr=SBIRT