Chantix (varenicline) / Pfizer - LARVOL DELTA

Smoking Cessation Agent Use and Provider Cessation Advice Among Adults With Gastrointestinal Diseases: Prevalence, Trends, and Predictors (ACG 2026) - "Smoking cessation agents included bupropion, varenicline, and nicotine replacement therapy. The final pooled unweighted sample comprised 2,197 individuals. Over the 12-year study period, 4.7% of our population used smoking cessation agents, with prevalence ranging from 1.4% to 7.3%, and the most recent estimate at 4.8% in 2023. Among cessation agent users, the median age was 54 years, 67% were females, 85% were non-Hispanic White, while majority (68%) used bupropion only."

Clinical • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Tobacco Cessation

Smoking Cessation Engagement Is Associated With Improved Outcomes in Chronic Pancreatitis (ACG 2026) - "The cessation cohort comprised patients with documented cessation: pharmacotherapy (varenicline, bupropion, or nicotine replacement therapy) and/or smoking/tobacco cessation counseling (CPT codes); the comparator comprised active smokers with no cessation-related prescriptions or ICD-10 codes. After matching, 11,867 patients were included in each cohort; the median age was 55 years, and 67% were male. Cessation attempts were associated with lower 3-year risk of AP (13.2% vs. 15.1%; RR 0.870, 95% CI 0.798-0.949; p = 0.0015) and pancreatic malignancy (2.7% vs."

Diabetes • Metabolic Disorders • Pancreatic Cancer • Pancreatitis • Solid Tumor • Tobacco Cessation

Varenicline as a Repurposable Drug Candidate for ADRD Prevention. (PubMed, medRxiv) - "Varenicline use is associated with a lower risk of ADRD among older adults receiving smoking cessation therapy. Further investigation of varenicline as a potential strategy for ADRD prevention is warranted. These findings underscored the value of explainable AI-guided approaches to drug repurposing."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Tobacco Cessation

Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial (clinicaltrials.gov) - P4 | N=794 | Not yet recruiting | Sponsor: Yale University

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

Tobacco Use Treatment: Synopsis of the 2026 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline. (PubMed, Ann Intern Med) - "Key recommendations for increasing abstinence from combustible tobacco include recommending motivational interviewing to increase engagement in treatment of tobacco and nicotine use (strong) and use of U.S. Food and Drug Administration-approved pharmacotherapies (strong), with varenicline recommended over monotherapy with other agents (strong), combination nicotine replacement therapy ([NRT] for example, patch plus lozenge) recommended over NRT monotherapy (single agent) (strong), and extending use of bupropion sustained release beyond 12 weeks (weak). Other key recommendations include varenicline for increasing abstinence from smokeless tobacco (strong) and electronic nicotine delivery systems (weak) and use of NRT or varenicline to increase quit attempts and abstinence in patients not ready to quit in the next 30 days (weak)."

Clinical guideline • Journal

Progress in the use of smoking cessation medications for vaping cessation: a review (ERS 2026) - "Aims: To synthesize contemporary research on the efficacy and safety of nicotine replacement therapy (NRT), varenicline, and bupropion for vaping cessation. Smoking cessation medications, particularly varenicline, offer significant potential for treating e-cigarette dependence. Future research must prioritize large-scale, vaping-specific randomized controlled trials to establish definitive clinical protocols."

Review • Insomnia • Nicotine Addiction • Sleep Disorder • Tobacco Addiction • Tobacco Cessation

Evaluation of Smoking Cessation Success Rate and Its Effective Factors in Patients Referring to the Smoking Cessation Clinic of Farshchian Specialized Heart Hospital in Hamadan, Iran. (PubMed, Addict Health) - "Varenicline was the primary medication, with 32.4% reporting side effects, mainly nausea. According to the results, the academic clinic can be effective in helping patients to quit smoking as a major risk factor in many non-communicable diseases."

Journal • CNS Disorders • Infectious Disease • Mental Retardation • Psychiatry • Tobacco Cessation

Emergency Department Management of Nicotine Use: A White Paper Prepared for the American Academy of Emergency Medicine. (PubMed, J Emerg Med) - "Emergency physicians have an important opportunity to meaningfully reduce morbidity and mortality for patients with NUD by starting safe and evidence-based NUD treatments. We recommend that all patients with NUD presenting to the acute care setting be offered medications for NUD as well as brief counseling on NUD, and be referred to local outpatient follow up or other available resources for continued NUD care on discharge."

Journal • CNS Disorders • Nicotine Addiction • Psychiatry • Tobacco Cessation

Long-Term Rural-Urban Trends in Tobacco Use, Cessation Interventions, and Lung Cancer Screening - 10-Year Retrospective Cohort Study (IASLC-WCLC 2026) - "Cessation interventions included documented counseling, nicotine replacement therapy, and bupropion and/or varenicline prescriptions. These patterns underscore the need for effective efforts to mitigate barriers to smoking cessation and lung cancer screening across all populations, particularly rural areas. There is also need for data systems to address limitations inherent in clinical data."

Retrospective data • Lung Cancer • Oncology • Solid Tumor • Tobacco Cessation

V-TMS: Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study) (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Sep 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • CNS Disorders • Nicotine Addiction • Psychiatry • Tobacco Addiction • Tobacco Cessation

TERRACOTTA (Targeting Treatable Traits in COPD to Prevent Hospitalisations): Targeting Treatable Traits (TTs) in Chronic Obstructive Pulmonary Disease (COPD) to Prevent Hospitalisations. (ANZCTR) - P=N/A | N=400 | Completed | Sponsor: Monash University | Recruiting ➔ Completed

Trial completion • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Personalised Smoking Cessation Support in a Lung Cancer Screening Programme: The Yorkshire Enhanced Stop Smoking Study (YESS) (IASLC-WCLC 2022) - "SC support comprised nicotine replacement therapy/e-cigarettes/varenicline/bupropion and behavioural support. The presence of a co-located stop smoking service and offer of immediate, opt-out delivery of behavioural and pharmacological support for quitting results in a high uptake by people who smoke attending for a LHC. Quit rates were considerably higher 3-months post-LHC, regardless of adding the personalised intervention, reinforcing the need for continued support. Further research is needed as to the efficacy of providing personalised lung and heart health information in addition to best practice SC support."

Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tobacco Cessation

Association of Major Adverse Cardiovascular Events with Varenicline versus Bupropion (AHA 2026) - "Abstract is embargoed at this time."

Adverse events • Cardiovascular

Cost-effectiveness of nicotine metabolite ratio-guided smoking cessation therapy in China: a hybrid decision-analytic modeling study based on real-world data. (PubMed, J Med Econ) - "Under MIC, fast metabolizers (NMR ≥ 0.31) received varenicline, while slow metabolizers (NMR < 0.31) received either nicotine replacement therapy (NRT) or bupropion. MIC-Bupropion showed favorable expected economic performance relative to SC, whereas MIC-NRT was strictly dominated. Further comparative-effectiveness, budget-impact, and implementation studies are warranted before routine adoption."

Journal • Tobacco Cessation

Varenicline for Smoking Reduction in Veterans Not Ready To Quit (clinicaltrials.gov) - P4 | N=400 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Enrollment open • Nicotine Addiction • Tobacco Addiction

Peer Vaped Nicotine Use in Adolescents and Young Adults: Associations With Abstinence and Intervention Adherence During a Quit Attempt. (PubMed, Subst Use) - "Participants completed a three arm, 12-week trial of varenicline and counseling, placebo and counseling, or enhanced treatment-as-usual...Peer vaping behavior may be associated with adolescents' capacity to quit vaped nicotine. Interventions that directly address peer network influences may enhance vaping cessation outcomes."

Journal • Nicotine Addiction

BHS - Break the Habit Study: Puff vs Pill: Break the Habit Study: Effect of Nicotine Vaping Products vs Varenicline on Smoking Cessation Among People Experiencing Social Disadvantage. (ANZCTR) - P3 | N=872 | Active, not recruiting | Sponsor: UNSW | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Tobacco Cessation

Innovative Hybrid Microneedle Patch for Co-delivery of Varenicline and Melatonin: Development, Characterization, and Potential for Smoking Cessation. (PubMed, Pharm Dev Technol) - "The combination of varenicline and melatonin in the microneedle shows promise in overcoming the limitations of current smoking cessation therapies, offering a patient-friendly and effective intervention. Future studies should include comparisons with commercial therapies and ex vivo dissolution studies (Q8)."

Journal • Pain • Tobacco Cessation

International consensus recommendations for smoking cessation in type 2 diabetes from the DiaSmokeFree Working group. (PubMed, Diabetes Res Clin Pract) - "Adults with T2D who smoke require integrated, high-intensity cessation support throughout the quitting process to reduce diabetes-related complications and improve long-term health outcomes."

Journal • Review • Cardiovascular • Diabetes • Metabolic Disorders • Myocardial Infarction • Tobacco Cessation • Type 2 Diabetes Mellitus • CYP1A2

Neuropharmacology of Nicotine Addiction and Therapeutic Strategies for Smoking Cessation. (PubMed, Biology (Basel)) - "Current treatment approaches include nicotine replacement therapies, antidepressant-based interventions, and partial nAChR agonists such as varenicline and cytisine. Emerging strategies encompass subtype-selective ligands, allosteric modulators, immunotherapeutics, neuromodulation techniques, and digital health technologies aimed at improving cessation outcomes. This review summarizes the neuropharmacological mechanisms underlying nicotine addiction and critically examines current and emerging therapeutic strategies, highlighting their mechanisms of action, clinical efficacy, limitations, and future potential for tobacco cessation."

IO biomarker • Journal • Review • CNS Disorders • Nicotine Addiction • Psychiatry • Tobacco Cessation

Bridging evidence gaps: the role of real-world data in tobacco harm reduction. (PubMed, Harm Reduct J) - "RCTs have shown a variety of quit methods (e.g., nicotine replacement therapy, varenicline, and electronic nicotine delivery systems (ENDS)) to be effective for smoking cessation, but these treatments have varying uptake and success in real-world settings...RWE can also advance our limited current understanding of how consumers use reduced-risk products, which could in turn improve generalizability of RCTs in the future, as well as inform clinical communications and regulatory strategies. Since RWE has limitations such as confounding and selection bias, it should be used as a complement, not a replacement for, traditional RCT evidence."

Journal • Real-world evidence • Tobacco Cessation

Access barriers and cost of varenicline for smoking cessation: A national comparative analysis of Medicare standalone part D and Medicare Advantage plan. (ASCO 2024) - "Varenicline prices in both PDPs and MAPDs were much higher than benchmarks. Compared to PDPs, MAPDs used more prior authorization and quantity limit to control cost. This can create access barriers to this cost-effective medication, burdening patients, physicians, health systems, and pharmacies."

Medicare • Reimbursement • US reimbursement • Oncology • Tobacco Cessation

Varenicline as a Treatment for Cannabis Use Disorder (clinicaltrials.gov) - P2 | N=224 | Not yet recruiting | Sponsor: Medical University of South Carolina

New P2 trial • Substance Abuse

E-cigarette use and nicotine dependence among hospitalized youth: influence of nicotine metabolism and CYP2A6 variability. (PubMed, Subst Use Misuse) - "The predominance of fast metabolizers among dependent youth suggests varenicline may be more appropriate than NRT as first-line treatment. Future work should evaluate metabolism-informed cessation treatment for youth."

Journal • Nicotine Addiction • CYP2A6

Anhedonia and neuropsychotropics: A pharmacovigilance-pharmacodynamic study. (PubMed, Therapie) - "Among neuropsychotropics, serotonin reuptake inhibitors, benzodiazepine anxiolytics and antipsychotics are associated with anhedonia reports. We were unable to find any correlation between anhedonia reports with antidepressants and their direct effects on monoamine transporters."

Adverse events • Journal • PK/PD data • Anesthesia • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease • ROR1