Chantix (varenicline) / Pfizer - LARVOL DELTA

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening (clinicaltrials.gov) - P=N/A | N=3228 | Completed | Sponsor: Abramson Cancer Center at Penn Medicine | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Solid Tumor • Tobacco Cessation

Top 20 Research Studies of 2024 for Primary Care Physicians. (PubMed, Am Fam Physician) - "Based on a network meta-analysis, the oral antibiotics most likely to be effective for community-acquired pneumonia are telithromycin (not available in the United States), azithromycin, amoxicillin-clavulanate, and the quinolones levofloxacin and nemonoxacin (not available in the United States). The oral antivirals molnupiravir and nirmatrelvir-ritonavir reduce hospitalizations in immunocompromised patients with COVID-19. In average-risk infants, a single dose of nirsevimab reduces hospitalizations due to respiratory syncytial virus...Low-dose amitriptyline is effective as second-line therapy for irritable bowel syndrome...Phentermine-topiramate and GLP-1 receptor agonists are the most effective drugs for promoting weight loss...For patients who do not quit smoking after a trial of varenicline or combined nicotine replacement therapy, a higher dose of either drug can increase quit rates...Oral naltrexone and acamprosate are safe and effective treatments for alcohol use..."

Journal • Review • Addiction (Opioid and Alcohol) • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Congestive Heart Failure • Diabetes • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Heart Failure • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Nephrology • Novel Coronavirus Disease • Obesity • Otorhinolaryngology • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • Sinusitis • Type 2 Diabetes Mellitus

Provision of recent advice to quit smoking by healthcare providers in Canada: Findings from the 2022 Canada International Tobacco Control Smoking and Vaping Survey. (PubMed, Prev Med Rep) - "Almost half consulted an HP (48.7 %); among those, 51.0% received cessation advice: 46.8 % were advised to use nicotine replacement therapy, 32.0 % varenicline, 14.0 % bupropion, 13.3 % a quitline, 14.5 % a smoking cessation program, and 2.6 % an e-cigarette. There were no significant differences by SDH, mental health, lung disease, or alcohol use. The low rate of smoking cessation advice from HPs underscores the need for systematic engagement across clinical settings to encourage quitting smoking and offer evidence-based methods to support cessation."

Journal • Cardiovascular • CNS Disorders • Depression • Heart Failure • Mood Disorders • Nicotine Addiction • Psychiatry • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

Do lab-based assessments of pretreatment smoking reinforcement and cue-specific craving predict smoking cessation with varenicline? (PubMed, Psychol Addict Behav) - P3 | "This study highlights the theoretical importance of smoking reinforcement and the predictive utility of Choice Behavior under Cued Conditions in identifying those at risk for relapse."

Clinical • Journal • Tobacco Cessation

Identifying treatment responders to the combination of varenicline and naltrexone. (PubMed, Am J Addict) - "These findings highlight candidate variables that, with further validation, may support the development of personalized treatment strategies."

Clinical • Journal • CNS Disorders • Depression • Psychiatry • Tobacco Cessation

Cigarette smoking and chronic disease in the United States, 2021-2023. (PubMed, Prev Med) - "There are 9.9 million people with chronic disease who smoke cigarettes daily in the U.S; findings highlight opportunity for healthcare providers to enhance efforts to help people quit smoking, opportunity to improve low use rates of FDA-approved smoking cessation pharmacotherapies, and potential for e-cigarettes as a smoking cessation tool."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Diabetes • Heart Failure • Immunology • Metabolic Disorders • Myocardial Infarction • Nicotine Addiction • Oncology • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework: The Tlogela Trial protocol. (PubMed, Contemp Clin Trials) - P2/3 | "Results will inform which intervention components, and in what combination, are most efficacious in supporting smoking abstinence among PLWH in SA and those that have the greatest potential for effectiveness when brought to scale."

Journal • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation

Combining Varenicline and Guanfacine for Smoking Cessation (clinicaltrials.gov) - P2 | N=165 | Completed | Sponsor: Yale University | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Apr 2025 | Trial primary completion date: Jul 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Tobacco Cessation

How to facilitate smoking cessation. (PubMed, Prog Cardiovasc Dis) - "These include brief counseling, cognitive and behavioral interventions, and pharmacological therapies (e.g. nicotine replacement therapy, bupropion, varenicline). We also discuss evidence regarding eHealth-based interventions and the potential impact of e-cigarettes on smoking cessation. Finally, we focus on the role of public health interventions in promoting smoking cessation."

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

Switchable synthesis of benzimidazole/quinoxaline C-glycosides with o-phenylenediamines and sulfoxonium ylide glyco-reagents. (PubMed, Chem Commun (Camb)) - "The process is adaptable as it can generate a variety of heteroarene C-glycosides by accommodating a wide range of sugar donors. It is also ideal for the modification of compounds like varenicline due to its excellent functional group compatibility, mild reaction conditions, and wide substrate range."

Journal

Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells. (PubMed, Regul Toxicol Pharmacol) - "After 24-h exposure, five EAT-positive NDSRIs, N-nitroso-duloxetine, N-nitroso-fluoxetine, N-nitroso-lorcaserin, N-nitroso-nortriptyline, and N-nitroso-varenicline, significantly induced DNA damage in both 2D and 3D models and increased MN and γH2A.X formation in 3D spheroids...The five EAT-negative NDSRIs, N-nitroso-diclofenac, N-nitroso-folic acid, N-nitroso-paroxetine, N-nitroso-desvaleryl-valsartan, and N-nitroso-desvaleryl-valsartan methyl ester, showed no DNA damage or MN formation in either model...Overall, the ten NDSRIs exhibited the same positive/negative genotoxicity outcomes in both the EAT and 3D HepaRG spheroids. These findings support the use of 3D HepaRG spheroids as an alternative in vitro model for detecting NDSRI-induced genotoxicity and confirming NDSRI responses in the EAT."

Journal

A multi-site study examining the tobacco withdrawal trajectory in people with tobacco and cannabis co-use. (PubMed, Drug Alcohol Depend) - "People who co-use experience greater tobacco withdrawal severity one-week post abstinence compared to people who only use tobacco. Personalized interventions that target immediate tobacco withdrawal and/or cannabis use may help improve tobacco cessation rates for people who co-use both substances."

Journal • Nicotine Addiction • Tobacco Cessation

TTOP: Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment (clinicaltrials.gov) - P2 | N=126 | Active, not recruiting | Sponsor: Joseph Valentino, MD | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Tobacco Cessation

Vape CAT: E-cigarette Cessation in Adults Who Co-use Cannabis (clinicaltrials.gov) - P4 | N=105 | Recruiting | Sponsor: Medical University of South Carolina | Trial completion date: Dec 2026 ➔ Sep 2026 | Trial primary completion date: Oct 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Nicotine Addiction • Tobacco Addiction

Treatment for smoking cessation : situation in 2025 (PubMed, Rev Med Suisse) - "Nicotine replacement therapy and bupropion are currently the only approved medications for smoking cessation in Switzerland. Since varenicline was withdrawn, cytisine-an older drug with a similar mechanism of action-has seen renewed interest. Recent studies confirm its effectiveness and acceptability."

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

Baseline predictors of smoking cessation among individuals with current or past major depressive disorder following treatment with varenicline and intensive behavioral treatment. (PubMed, Drug Alcohol Depend) - "Varenicline should be a primary treatment consideration for individuals with MDD. Stable psychiatric status is not required for favorable treatment outcome. Further effort is needed to identify behavioral interventions that can be added to varenicline to improve quit rates for individuals with MDD."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Tobacco Cessation

Contingency Management to Promote Smoking Cessation (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: University of Kansas Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ Aug 2025

Enrollment open • Trial completion date • Trial primary completion date • Tobacco Cessation

Tlogela: Evaluating Smoking Cessation Interventions for PWH in South Africa (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Aug 2028 ➔ Aug 2027 | Trial primary completion date: Aug 2028 ➔ Aug 2027

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation

A Randomized, Controlled Trial of Varenicline for E-cigarette Cessation (clinicaltrials.gov) - P2 | N=326 | Not yet recruiting | Sponsor: Yale University

New P2 trial • Nicotine Addiction • Oncology

The Effectiveness of Smoking Cessation in Prediabetic Smokers (clinicaltrials.gov) - P=N/A | N=589 | Active, not recruiting | Sponsor: National Taiwan University Hospital | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Metabolic Disorders • Tobacco Cessation

Development of Fluorine-18 Labeled Radioligands for PET Imaging of Chemogenetics in Monkey Brain (SNMMI 2025) - "The PSAM variant PSAM4 (α7-nAChRL131G, Q139L, Y217F) was developed, with ultrapotent PSEMs like uPSEM792 and uPSEM815 derived from varenicline, an FDA-approved anti-smoking drug [1]... A total of 28 new chemogenetic ligands were obtained with lipophilicity better than uPSEM792 for brain entry. The binding assay revealed two promising candidates, PSG07 and PSN09 to PSAM4-GlyR with Ki values of 4.22 nM, and 1.86 nM, respectively. Interestingly, PSG07 and PSN09 also demonstrated good PSAM4-5-HT3 binding affinity with lower than 10 nM (Figure 1A)."

Preclinical • CNS Disorders

Pilot Trial of a Behavioral Economics-Informed Clinical Decision Support Alert to Improve Inpatient Tobacco Use Treatment Rates. (PubMed, Nicotine Tob Res) - "Compared to the standard electronic practice reminders, behavioral economics-informed clinical decision support alerts increased referrals to outpatient tobacco use treatment services for inpatients who smoke, but did not increase tobacco treatment intervention rates during the inpatient stay. Several variables appear to influence rates of tobacco use treatment, including number of alert interactions and patient race. This pilot study suggests the barriers to inpatient tobacco interventions may be complex and therefore insensitive to simple behavioral economic nudges."

Journal

Predictors of smoking abstinence among diabetic smokers: Evidence from the French national smoking cessation registry CDTnet. (PubMed, PLoS One) - "Positive predictors of abstinence among diabetic smokers included employment (odds ratio [OR], 1.61; 95% confidence interval [CI], 1.37-1.89), ≥ 3 prior quit attempts (OR, 1.61; 95% CI, 1.36-1.91), low nicotine dependence (OR, 1.42; 95% CI, 1.13-1.78), prescription of combined nicotine replacement therapy (NRT) (OR, 1.43; 95% CI, 1.19-1.72) or varenicline (OR, 1.64; 95% CI, 1.20-2.25), and ≥7 SCS consultations (OR, 4.47; 95% CI, 3.40-5.84). Conversely, negative predictors included history of myocardial infarction/angina (OR, 0.82; 95% CI, 0.70-0.96), chronic bronchitis/chronic obstructive pulmonary disease (OR, 0.79; 95% CI, 0.69-0.91), anxiety (OR, 0.82; 95% CI, 0.71-0.94), recent cannabis use (OR, 0.67; 95% CI, 0.50-0.90), and exclusive oral NRT use (OR, 0.70; 95% CI, 0.56-0.88). Overall, tailored cessation programs are crucial for enhancing cessation outcomes among diabetic smokers."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Mood Disorders • Myocardial Infarction • Nicotine Addiction • Psychiatry • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

HARP: Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol) • Human Immunodeficiency Virus • Infectious Disease • Nicotine Addiction • Tobacco Addiction

Vape CAT: E-cigarette Cessation in Adults Who Co-use Cannabis (clinicaltrials.gov) - P4 | N=105 | Recruiting | Sponsor: Medical University of South Carolina | Trial primary completion date: Jul 2026 ➔ Oct 2026

Trial primary completion date • Nicotine Addiction • Tobacco Addiction