Semi-PBPK Modeling and Simulation to Evaluate the Local and Systemic Pharmacokinetics of OC-01(Varenicline) Nasal Spray
This study aimed to build a nasal semi-physiologically based pharmacokinetic (PBPK) model to predict the intranasal pharmacokinetic (PK) of the OC-01(varenicline) nasal spray and accelerate the development of this drug. Based on the physiology of the human upper respiratory system, the semi-PBPK model was established and validated using systemic plasma PK data of varenicline previously observed in Americans and Chinese. Drug concentrations, both in respiratory tissue and plasma circulation system, were well simulated, and it was indicated that local concentration at the target site (nasal cavity) was significantly higher t...
Source: Frontiers in Pharmacology - July 7, 2022 Category: Drugs & Pharmacology Source Type: research
Developing a Smoking Cessation Intervention for People With Severe Mental Illness Treated by Flexible Assertive Community Treatment Teams in the Netherlands: A Delphi Study
ConclusionsThis study provides insight into expert consensus on the core components of a smoking cessation intervention for people with SMI. The results of this study were used for the development of a comprehensive smoking cessation program. (Source: Frontiers in Psychiatry)
Source: Frontiers in Psychiatry - July 6, 2022 Category: Psychiatry Source Type: research
A systematic review and meta-analysis of interventions to induce attempts to quit tobacco among adults not ready to quit.
Experimental and Clinical Psychopharmacology, Vol 31(2), Apr 2023, 541-559; doi:10.1037/pha0000583The prevalence of past-year smoking cessation remains below 10% in the U.S. Most who smoke are not ready to quit in the near future. Cessation requires both (a) initiating a quit attempt (QA) and (b) maintaining abstinence. Most research has focused on abstinence among people already motivated to quit. We systematically reviewed interventions to promote QAs among people not motivated to quit tobacco. We searched PubMed, CENTRAL, PsycINFO, Embase, and our personal libraries for randomized trials of tobacco interventions that re...
Source: Experimental and Clinical Psychopharmacology - June 30, 2022 Category: Psychiatry & Psychology Source Type: research
S3 Guideline “Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment” – Short Version
Introduction: In addition to the prevention of tobacco consumption, the establishment and assurance of high-quality treatment for harmful use and dependence on tobacco products remains an important health-related task in Germany. Regular updating of the Association of the Scientific Medical Societies (AWMF) S3 guideline “Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment” (Tobacco Guideline) offers a sustainable and reputable source of knowledge on smoking cessation.Methods: Under the auspices of the German Society for Psychiatry, Psychotherapy, Psychosomatics, and Neurology (DGPPN) and the German Soci...
Source: European Addiction Research - June 27, 2022 Category: Addiction Source Type: research
IJERPH, Vol. 19, Pages 7757: Abstinence Rate, Adverse Events and Withdrawal Symptoms after Varenicline Use and Predicting Factors of Smoking Abstinence: A Multicentre Single-State Study in Malaysia
Conclusion: Almost two-thirds of the subjects achieved smoking abstinence with varenicline. The duration of the treatment, as well as the patients’ ages had a significant influence on successful smoking abstinence. Rare cases of cardiovascular and neuropsychiatric-related adverse events were reported, warranting continuous surveillance and adverse drug reaction reporting. (Source: International Journal of Environmental Research and Public Health)
Source: International Journal of Environmental Research and Public Health - June 24, 2022 Category: Environmental Health Authors: Shea Jiun Choo Chee Tao Chang Balamurugan Tangiisuran Mohd Faiz Abdul Latif Nor Aida Sanusi Sabariah Noor Harun Tags: Article Source Type: research
Update on Dry Eye Disease —Reply
In Reply Dr Wirta ’s Letter discusses varenicline nasal spray as a potential treatment option for dry eye disease. This drug, which was approved after submission of our clinical update, is an exciting addition to the current armamentarium of therapies for dry eye disease. The goal of our article was to provide an o verview of the pathophysiology of dry eye disease, an approach to evaluating patients, and a review of current treatment strategies for clinicians practicing outside the field of ophthalmology. Therefore, we felt that discussion of pipeline treatments and those under investigation was beyond the sco pe of our ...
Source: JAMA - June 21, 2022 Category: General Medicine Source Type: research
Update on Dry Eye Disease
To the Editor The recent JAMA Insights article about the pathophysiology, diagnosis, and treatment of dry eye disease provided clear and concise information for practicing clinicians. However, other approaches for treatment of dry eye disease could have been mentioned, such as OC-01 (varenicline solution) nasal spray. In the primary phase 3 trial (ONSET-2) that included 758 patients with dry eye disease, treatment with OC-01 (varenicline solution) nasal spray for 4 weeks improved tear production and patient-reported symptoms compared with vehicle (control) nasal spray. In October 2021, this drug was approved by the US Food...
Source: JAMA - June 21, 2022 Category: General Medicine Source Type: research
Counseling Plus Varenicline May Improve Smoking Cessation Among Black Adults
Black smokers may be more likely to stop smoking if prescribed varenicline in addition to counseling sessions, suggests areport published this week inJAMA.“Black adults in the US have higher rates of smoking-related morbidity and mortality compared with White adults, despite having comparable smoking prevalence and smoking fewer cigarettes per day,” wrote Lisa Sanderson Cox, Ph.D., of the University of Kansas School of Medicine and colleagues. “ Although they report greater interest in quitting, Black smokers are less likely than White smokers to be advised to quit or achieve sustained smoking abstinence and have bee...
Source: Psychiatr News - June 16, 2022 Category: Psychiatry Tags: abstaining Black adults counseling JAMA side effects smoking cessation varenicline Source Type: research
Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers
This randomized, double-blind, placebo-controlled trial examines the efficacy of varenicline in combination with counseling for smoking cessation among Black adults who are daily smokers. (Source: JAMA)
Source: JAMA - June 14, 2022 Category: General Medicine Source Type: research
P28. Effects of Varenicline on Tobacco Craving and Withdrawal in Smokers With and Without Schizophrenia
People with schizophrenia (SCZ) have significantly higher tobacco smoking rates and lower quit rates than the general population. Varenicline, a partial agonist at α4β2 nicotinic acetylcholine receptors (nAChRs) is an effective pharmacotherapy for non-psychiatric smokers, however, investigation into its effects in SCZ are less well-studied and mechanisms may differ from non-psychiatric controls due to dysregulation in nAChR neurotransmission associated with SCZ. Here, we investigate whether varenicline attenuates acute abstinence-induced increases in craving and withdrawal in patients with SCZ versus controls. (Source: B...
Source: Biological Psychiatry - April 28, 2022 Category: Psychiatry Authors: Samantha Johnstone, Maryam Sorkhou, Tony George Source Type: research
P39. Changes in Attentional Bias Following Varenicline Treatment in Cigarette Smokers
Among cigarette smokers, attentional bias (AB) to smoking cues has been associated with increased smoking urges and greater probability of relapse. We investigated whether varenicline treatment alters AB to smoking cues, and whether eye-tracking can serve as a proxy measure for changes in neural responses. (Source: Biological Psychiatry)
Source: Biological Psychiatry - April 28, 2022 Category: Psychiatry Authors: Noreen Rahmani, Jonathan Chung, Moshe Eizenman, Pingping Jiang, Peter Selby, Laurie Zawertailo Source Type: research
Cigarette Use Fell From 2006 to 2019 Among Those With Depression, Substance Use Disorder
This study shows us that, at a population-level, reductions in tobacco use are achievable for people with psychiatric conditions, and smoking cessation should be prioritized along with treatments for substance use, depression, and other mental health disorders for people who experience them,” N ora Volkow, M.D., director of the National Institute on Drug Abuse (NIDA) and co-author of the study, said in anews release. “Therapies to help people stop smoking are safe, effective, and may even enhance the long-term success of concurrent treatments for more severe mental health symptoms in individuals with psychiatric disord...
Source: Psychiatr News - April 26, 2022 Category: Psychiatry Tags: Alaska Natives American Indians cigarette JAMA major depressive episode NIDA Nora Volkow past-month use Source Type: research
