Chantix (varenicline) / Pfizer - LARVOL DELTA

Optimizing Tobacco Use Treatment for PLWHA (clinicaltrials.gov) - P3 | N=340 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

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

Inpatient Tobacco Cessation Counseling and Treatment: A Survey of U.S.-Based Cardiologists. (PubMed, JACC Adv) - "Although tobacco cessation is critical posthospitalization, most hospitals do not have tobacco cessation teams, and most cardiologists do not assist their patients in quit attempts. Although improving knowledge among cardiologists is important, policy changes to incentivize hospital-wide adoption of such programs is crucial to increase availability."

Journal • Cardiovascular • Tobacco Cessation

Treatment of primary adult-onset neurodegenerative cerebellar ataxias. (PubMed, Neurotherapeutics) - "Pharmacological approaches, including omaveloxolone for Friedreich's ataxia and off-label agents such as riluzole, 4-aminopyridine, and varenicline, demonstrate subtype-specific benefits. In parallel, molecular and gene-based therapies-including antisense oligonucleotides, viral vector delivery systems, and CRISPR-based strategies-are advancing into preclinical and early-phase clinical studies. This evolving therapeutic landscape underscores a shift toward personalized, multimodal care for cerebellar ataxias and highlights the need for continued translational efforts to bridge mechanistic insights with clinical impact."

Journal • Review • Ataxia • CNS Disorders • Friedreich ataxia • Movement Disorders

Cannabis Use and Nicotine Vaping Cessation Outcomes: A Secondary Analysis of a Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P4 | "Varenicline proved helpful for nicotine vaping cessation regardless of cannabis use, indicating that co-use of cannabis may not represent a barrier to successful nicotine vaping cessation treatment. ClinicalTrials.gov Identifier: NCT05367492."

Clinical • Journal • Nicotine Addiction • Substance Abuse

Mucoadhesive bilayer nanomicelles-in-nanofibers nasal insert for sustained treatment of dry eye disease. (PubMed, Eur J Pharm Biopharm) - "The current study involves the development of innovative non-invasive single-dose mucoadhesive varenicline (VAR)-loaded biodegradable and biocompatible nanomicelles-in-nanofibers (NFs) nasal insert for DED treatment...In-vivo evaluation including analysis of histological micrographs of the corneal structure, revealed clear signs of structure improvement. The newly developed VAR-NPs-in-NFs nasal inserts can serve as an effective alternative to conventional eye drops for treating DED and offer a progressive strategy with considerable potential for broader application across various ocular diseases beyond DED."

Journal • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

Varenicline for Smoking Reduction in Veterans Not Ready To Quit (clinicaltrials.gov) - P4 | N=400 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Sep 2030 ➔ Mar 2031 | Initiation date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Sep 2030 ➔ Mar 2031

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

Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial. (PubMed, Contemp Clin Trials) - P3 | "This study will test the effectiveness of a scalable and comprehensive tobacco use treatment approach with medication plus digital behavioral support in a low- and middle-income country setting, paired with examination of implementation and cost-effectiveness. This research has the potential to improve the health of PWH by demonstrating the health effects of a tobacco cessation treatment package that aims to reduce the morbidity and mortality associated with smoking. Trial Registration clinicaltrials.gov #NCT05786547, Registered 27 March 2023."

Journal • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation

Pharmacological interventions to manage cardiometabolic outcomes in adults with severe mental illness: umbrella review. (PubMed, Br J Psychiatry) - "Pharmacological interventions can improve cardiometabolic outcomes in adults with SMI when non-pharmacological interventions are either insufficient alone, impractical or unacceptable. However, licensed treatments have been reviewed in relatively low numbers. Improving cardiometabolic outcomes is a key area in psychiatry, and the results of this review will be important in shaping future guidance."

Journal • CNS Disorders • Dyslipidemia • Psychiatry • Tobacco Cessation

From Varenicline to Neuroleptic Malignant Syndrome: The Complex Effects of Smoking Cessation on Dopamine Regulation. (PubMed, Prim Care Companion CNS Disord) - No abstract available

Journal • Tobacco Cessation

Effects of varenicline as an adjunct to analgesic and anti-inflammatory therapy in acute nerve injury. (PubMed, Injury) - "Varenicline, as an adjunct to meloxicam, enhances neuroprotection, reduces inflammation, and promotes histological and biochemical indicators of regeneration in rats with acute sciatic nerve injury. Future studies should explore its long-term effects and potential as a monotherapy for peripheral nerve injuries."

Journal • Fibrosis • Immunology • Inflammation • Neuralgia • Pain • IL6

SMARTTT: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV (clinicaltrials.gov) - P4 | N=323 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

Smoking cessation provision and outcomes following initiation of a new smoking cessation service alongside an urgent suspect lung cancer clinic (BTS WM 2025) - "Methods A new standard operating procedure for outpatient provision of SC interventions was developed, including brief guides to prescribing Varenicline and Cytisine as well as reminders regarding web referral to the local authority provided stop smoking service (LSSS)...2021. DOI:10.7326/M21–0252"

Infectious Disease • Lung Cancer • Oncology • Solid Tumor • Tobacco Cessation

Interventions for quitting vaping. (PubMed, Cochrane Database Syst Rev) - "Low-certainty evidence suggests that text message-based interventions to help people stop nicotine vaping may help more youths and young adults to successfully stop compared to no/minimal support, with very uncertain evidence regarding their effect on smoking behaviours. Low-certainty evidence suggests that varenicline may help people quit vaping. Data exploring the effectiveness of combination NRT, cytisine, and nicotine/vaping behaviour reduction are inconclusive due to risk of bias and imprecision. Most studies that measured SAEs reported that none had occurred; however, more data are needed to draw clear conclusions. Studies that have investigated these interventions for quitting smoking have not demonstrated serious concerns about SAEs. It is important that future studies measure combustible tobacco outcomes so the complete risk profile of relevant interventions can be considered. Further RCTs are underway. To ensure this review continues to provide up-to-date..."

Clinical • Journal • Review • Oncology • Tobacco Cessation

Characterization of Tobacco Cessation Services, Pharmacotherapies, and Policies at Adolescent-serving Substance Use Treatment Facilities in 2023. (PubMed, J Addict Med) - "While most adolescent-only substance use treatment facilities offered tobacco cessation education or counseling and restricted tobacco use at their sites, they were less likely than adult/adolescent facilities to offer pharmacotherapy for tobacco cessation. This reflects a missed opportunity to offer robust options to treat tobacco use among adolescents with substance use disorders."

Journal • Tobacco Cessation

Comparative Risk of New-Onset Seizure Among Smoking Cessation Pharmacotherapies (AES 2025) - "A p-value of < 0.05 was considered significant. Nicotine replacement therapy (NRT) (1,417; 27%), varenicline (3,153; 62%), bupropion sustained-release (244; 5%), or combination therapy (328; 6%) were used. This study demonstrates that overall incidence of new-onset seizures is high in tobacco smokers started on SCT. When comparing treatment groups, increased risk of new-onset seizure was identified only with NRT relative to varenicline. Although smoking cessation has significant health benefits, patients on SCT require close monitoring for seizure occurrence."

CNS Disorders • Epilepsy • Tobacco Cessation

Does varenicline promote abstinence in youths who vape? (PubMed, Expert Opin Pharmacother) - "The results of ViVA do not apply to adults, and those youths who are not actively seeking to stop vaping, and youths who smoke and are, probably, addicted to smoking/nicotine. Longer-term clinical trials in both youths and adults will be necessary to determine whether varenicline causes meaningful abstinence and is safe in long-term vaping."

Journal • Review

Targeted Therapies and Pharmacologic Advances in Mucous Membrane Pemphigoid: A Comprehensive Review. (PubMed, Dermatol Pract Concept) - "Considering the severity of the condition, progressive fibrosis, and resistance to therapy, more research is required in relation to the pathogenesis of MMP and the efficacy and safety profile of novel pharmacological options. Pharmacological agents should provide the achievement and maintenance of remission with minimal adverse effects. A broader spectrum of pharmacological agents will allow a personalized approach and more alternatives, in particular for recalcitrant cases, failure of the previous therapy, and in patients with MMP and malignancy."

Journal • Review • Dermatology • Fibrosis • Immunology • Infectious Disease • Oncology

Efficacy of Varenicline Tartrate in Treating Frequent Premature Ventricular Contractions (clinicaltrials.gov) - P2 | N=116 | Completed | Sponsor: Yihan Chen | Phase classification: P3 ➔ P2

Phase classification

Value Based Purchasing to Increase Tobacco Cessation Counseling and Medications in Behavioral Health Homes. (PubMed, Community Ment Health J) - "Comparisons with other in-network behavioral health service users without BHHP or VBP indicate higher receipt of TCC (p < .0001) and varenicline (p < .0001) among the BHHP VBP group. This study provides some evidence that value-based purchasing may be used to incentivize provider agencies with behavioral health homes to increase access to tobacco cessation treatment for individuals with behavioral health conditions."

Journal • Tobacco Cessation

Effect of Cytisine on Ventricular Repolarization Parameters in Healthy Smokers. (PubMed, Turk Kardiyol Dern Ars) - "In healthy smokers, approximately one month of cytisine treatment was not associated with statistically significant changes in QT, QTc, Tp-e, or Tp-e/QTc. These results suggest that there is no detectable short-term effect on ventricular repolarization in this population. However, further prospective, randomized, and long-term studies are warranted to confirm these findings, particularly in patients with pre-existing cardiovascular conditions."

Journal • Cardiovascular • Tobacco Cessation

Cannabidiol Transiently Reduces Nicotine Vapor Self-Administration in Mice (Neuroscience 2025) - "First-line cessation aids, including nicotine replacement therapy, varenicline, and bupropion, show limited long-term efficacy. During 21- day chronic administration, we observe a transient decrease in nicotine self-administration during the first week, but not the second or third weeks of testing. Together the data help to elucidate the behavioral effects of CBD administration on nicotine intake behaviors and the potential of CBD as a nicotine cessation therapeutic."

Preclinical • CNS Disorders • Nicotine Addiction • Psychiatry

Behavioral effects of varenicline treatment in animal model of e-cigarrete exposure in adolescent Swiss mice (Neuroscience 2025) - "However, VAR also showed age- or sex-dependent behavioral alterations, depending on the test that was used. A neurochemical study is warranted to better understand the mechanisms associated with the observed behavioral alterations."

Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Psychiatry

Varenicline reverses hippocampal neurotransmitter dysregulation induced by adolescent cigarette smoke in female mice: a metabolomic investigation (Neuroscience 2025) - "The reversal of these effects by varenicline highlights its potential therapeutic value beyond smoking cessation, particularly for the developing brain and considering sex-specific vulnerabilities. Overall, this work advances understanding of the neurochemical impact of early nicotine exposure and supports pharmacological strategies adjusted to adolescents and sex-specific neurobiological contexts."

Preclinical • CNS Disorders • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

COMBO II: Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation (clinicaltrials.gov) - P2 | N=496 | Not yet recruiting | Sponsor: University of Oklahoma | Initiation date: Oct 2025 ➔ Jan 2026

Trial initiation date • Tobacco Cessation

Smoking Cessation Treatment for Head & Neck Cancer Patients (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Tobacco Cessation