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Addiction (Abingdon, England) Jul 2024To conduct a systematic review and meta-analysis and pool the incremental net benefits (INBs) of varenicline compared with behaviour support with bupropion or nicotine... (Meta-Analysis)
Meta-Analysis Review
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 I 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.
Topics: Humans; Varenicline; Smoking Cessation; Cost-Benefit Analysis; Smoking Cessation Agents; Bupropion; Tobacco Use Cessation Devices; Behavior Therapy; Adult
PubMed: 38520121
DOI: 10.1111/add.16464 -
Psychopharmacology Mar 2024It is unclear if e-cigarettes have reduced abuse liability relative to traditional cigarettes, especially when considering advanced devices which deliver nicotine more...
RATIONALE
It is unclear if e-cigarettes have reduced abuse liability relative to traditional cigarettes, especially when considering advanced devices which deliver nicotine more efficiently. Translatable and predictive animal models are needed to addresses this question.
OBJECTIVES
Our goal was to explore the subjective stimulus effects of e-cigarettes by training rats to discriminate puffs of nicotine aerosol from vehicle aerosol using an aerosol delivery system designed to model e-cigarette use patterns in humans.
METHODS
Rats were trained to discriminate between ten, 10 s puffs of aerosol generated from 3 mg/ml nicotine e-liquid and nicotine-free e-liquid using a food-reinforced operant procedure. Following acquisition, tests were conducted to determine the specificity of the nicotine aerosol stimulus as well as the impact to the stimulus effects of nicotine resulting from the addition of menthol to e-liquid.
RESULTS
Rats learned the nicotine aerosol puff vs vehicle puff discrimination in a mean of 25 training sessions. Injected nicotine fully substituted for the stimulus effects of nicotine aerosol. The stimulus effects of nicotine aerosol were blocked by the nicotinic receptor antagonist mecamylamine. The nicotinic receptor partial agonist, varenicline as well as the stimulant d-amphetamine substituted more robustly for nicotine aerosol puffs than did the NMDA antagonist, ketamine. Menthol enhanced the stimulus effects of nicotine aerosol without altering nicotine blood plasma levels.
CONCLUSIONS
Nicotine aerosol puffs can function as a training stimulus in rats. The stimulus effects were CNS-mediated and receptor specific. Menthol appears to enhance the stimulus effects of nicotine aerosol through a pharmacodynamic rather than pharmacokinetic mechanism.
PubMed: 38519818
DOI: 10.1007/s00213-024-06579-9 -
Respirology (Carlton, Vic.) Jun 2024Nicotine metabolic ratio (NMR) has been associated with nicotine metabolism and smoking characteristics. However, there are few studies on the potential association... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVE
Nicotine metabolic ratio (NMR) has been associated with nicotine metabolism and smoking characteristics. However, there are few studies on the potential association between NMR and smoking cessation efficacy in smokers with chronic obstructive pulmonary disease (COPD) in China or elsewhere.
METHODS
This study was a stratified block randomized controlled trial for smoking cessation in Chinese smokers with COPD. NMR was used as a stratification factor; slow metabolizers were defined as those with NMR <0.31, and normal metabolizers as those with NMR ≥0.31. Participants were randomly assigned to the varenicline or bupropion group. Follow-up visits were conducted at 1, 2, 4, 6, 9, 12 and 24 weeks.
RESULTS
Two hundred twenty-four participants were recruited and analysed from February 2019 to June 2022. In normal metabolizers, the 9-12 weeks continuous abstinence rate of varenicline (43.1%) was higher than in bupropion (23.5%) (OR = 2.47, 95% CI 1.05-5.78, p = 0.038). There was no significant difference in abstinence rates between treatment groups in slow metabolizers (54.1% vs. 45.9%, OR = 1.39, 95% CI 0.68-2.83, p = 0.366). For slow metabolizers, the total score of side effects in the varenicline group was significantly higher than the bupropion group (p = 0.048), while there was no significant difference in side effects between groups for normal metabolizers (p = 0.360).
CONCLUSION
Varenicline showed better efficacy than bupropion in normal metabolizers, and bupropion showed equivalent efficacy in slow metabolizers with less side effects. According to our study, NMR provides a better justification for both scientific research and tailoring optimal pharmacotherapy for smoking cessation among smokers in COPD.
Topics: Humans; Varenicline; Bupropion; Pulmonary Disease, Chronic Obstructive; Male; Female; Smoking Cessation; Middle Aged; Smoking Cessation Agents; Nicotine; Treatment Outcome; Aged; China; Smokers
PubMed: 38494828
DOI: 10.1111/resp.14702 -
Cureus Feb 2024The smoking epidemic is the greatest threat to global public health that has ever existed. Teenagers constantly perceive smoking as a way to communicate with friends and... (Review)
Review
The smoking epidemic is the greatest threat to global public health that has ever existed. Teenagers constantly perceive smoking as a way to communicate with friends and express their emotions. Adolescent smokers should be noticed immediately before the extended period of tobacco addiction and being resistant to the interventions. The aim of this study is to assess the effectiveness of healthcare interventions targeting smoking cessation in adolescents within low- and middle-income countries (LMICs) and to summarize the options, benefits, and affordability of interventions for quitting smoking that may be implemented in LMICs. The review highlights the effectiveness of various pharmacological interventions, such as nicotine replacement therapy (NRT), bupropion, nortriptyline, varenicline, and cytosine, shedding light on their respective success rates in aiding smoking cessation. Additionally, the study delves into the realm of behavioral interventions, emphasizing the significant impact of counseling, brief advice, and automated text messaging in promoting smoking cessation among adolescents. Furthermore, the review examines the influence of external factors, such as an increase in cigarette prices and changes in the smoking environment, on smoking habits. It underscores the importance of creating smoke-free areas and leveraging community involvement to enhance the effectiveness of interventions. The study also evaluates the affordability and sustainability of smoking cessation interventions, emphasizing the need for a balanced combination of pharmacotherapy and behavioral support. The advantages of quitting smoking will improve the nation's health and boost economic productivity.
PubMed: 38481929
DOI: 10.7759/cureus.54051 -
Pharmacopsychiatry May 2024Perceptions of cannabis as a potential medical treatment for mood and anxiety disorders have been increasing in the context of legalizations, availability, and medical...
Perceptions, Experiences, and Patterns of Cannabis Use in Individuals with Mood and Anxiety Disorders in the Context of Cannabis Legalization and Medical Cannabis Program in Canada - A Qualitative Study.
INTRODUCTION
Perceptions of cannabis as a potential medical treatment for mood and anxiety disorders have been increasing in the context of legalizations, availability, and medical cannabis programs, though current evidence predominately indicates risks and negative effects of cannabis use (CU) on mental health outcomes. This study aims to understand motivations, perceptions, effects, and patterns of CU in individuals with mood and anxiety disorders.
METHODS
Thirty-six adult patients diagnosed with mood or anxiety disorders, obsessive-compulsive disorder, or posttraumatic stress disorder who were currently using cannabis completed an in-depth qualitative interview on individual motivations, perceptions, experiences, effects, and patterns of their CU. The thematic analysis focused on phases of CU and sources of cannabis products and information.
RESULTS
Reported motivations for initiation of CU included curiosity, peer pressure, and dissatisfaction with conventional treatments. Factors such as psychotropic effects and coping with mental health symptoms and insomnia contributed to the continuation of CU. More negative effects, including cognitive dysfunction, worsening of mood, and anxiety symptoms, were acknowledged with ongoing CU. Concerning findings included common initiation of CU before age 18, combined medical and recreational CU, rare consultation of medical professionals on CU, and potential effects and harms.
DISCUSSION
Findings indicate individual complexity of motivations, perceptions, and patterns of CU in the study population. The reported potential beneficial effects of specific cannabis products should be further investigated. Findings emphasize patient-provider dialogue on both CU and conventional treatments. Information from this study can contribute to and inform the development of education, prevention, and intervention strategies.
Topics: Humans; Male; Female; Medical Marijuana; Adult; Canada; Anxiety Disorders; Middle Aged; Mood Disorders; Qualitative Research; Young Adult; Motivation; Cannabis; Perception
PubMed: 38467156
DOI: 10.1055/a-2264-1047 -
The Lancet Regional Health. Western... Apr 2024Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote...
BACKGROUND
Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote natural tear production in patients with dry eye disease. We therefore evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray versus vehicle in Chinese patients with dry eye disease.
METHODS
This was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 clinical trial conducted at ophthalmology departments in 20 hospitals across China (NCT05378945). Eligible patients had a diagnosis of dry eye disease based on patient symptoms, Eye Dryness Score (EDS), Schirmer's Test (with topical anesthesia) Score (STS), and corneal fluorescein staining (CFS) score. Participants were randomly assigned 1:1 using an Interactive Web Response System (IWRS) to receive OC-01 0.6 mg/mL twice daily (BID) or vehicle nasal spray. Participants, investigators, and sponsor were all masked to treatment assignment. The primary endpoint was the percentage of subjects in the intention-to-treat population achieving ≥10 mm improvement in STS from baseline at week 4.
FINDINGS
In total, 340 patients were randomized from 21 July 2022 to 04 April 2023, 78.8% were female. Patients in the OC-01 group (n = 176) had significantly higher achievement of ≥10 mm improvement in STS (35.8% [n = 63] versus 17.7% [n = 29], stratified odds ratio: 2.67, 95% CI: 1.570-4.533, p = 0.0002) and a significantly greater increase from baseline STS (least-squares mean difference [SE]: 3.87 [0.794], p < 0.0001) at week 4 versus the vehicle group (n = 164). In addition, OC-01 led to a numerically greater reduction in mean EDS from baseline at week 4 compared to the vehicle group (LS mean [SE] difference: -1.3 [2.20]; 95% CI: -5.64 to 2.99, p = 0.5467). The most common adverse event was mild, transient sneezing (78% of OC-01 administrations). No serious adverse events related to nasal administration occurred.
INTERPRETATION
OC-01 (varenicline solution) nasal spray BID has clinically meaningful efficacy for reducing the signs (as measured by STS) and may improve the symptoms (as measured by EDS) of dry eye disease, with an excellent safety and tolerability profile, in the Chinese population.
FUNDING
Jixing Pharmaceutical Co. Ltd.
PubMed: 38440130
DOI: 10.1016/j.lanwpc.2024.101032 -
BMC Public Health Mar 2024Adhering to varenicline has been shown to significantly improve the chances of successfully quitting smoking, with studies indicating a twofold increase in 6-month quit... (Review)
Review
BACKGROUND
Adhering to varenicline has been shown to significantly improve the chances of successfully quitting smoking, with studies indicating a twofold increase in 6-month quit rates. However, despite its potential benefits, many individuals struggle with maintaining good adherence to varenicline; thus there is a need to develop scalable strategies to help people adhere. As a first step to inform the development of an intervention to improve adherence to varenicline, we conducted a rapid literature review to identify: 1) modifiable barriers and facilitators to varenicline adherence, and 2) behaviour change techniques associated with increased adherence to varenicline.
METHODS
We searched MEDLINE, Embase, APA PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials for relevant studies published between 2006 and 2022. Search terms included "varenicline," "smoking cessation," and "adherence," and their respective subject headings and synonyms. We screened and included studies reporting modifiable determinants of adherence to varenicline and then assessed quality, extracted modifiable determinants and mapped them to the Theoretical Domains Framework version 2 and the Behaviour Change Technique Taxonomy version 1.
RESULTS
A total of 1,221 titles were identified through the database searches; 61 met the eligibility criteria. Most of the studies were randomized controlled trials and predominantly focused on barriers to varenicline. Only nine studies explicitly mentioned behaviour change techniques used to help varenicline adherence. Eight domains were identified as barriers to varenicline adherence (behavioural regulation, memory, goals, intentions, beliefs about capabilities, beliefs about consequences, optimism/pessimism, and environmental context) and five as facilitators (knowledge, behavioural regulation, beliefs about capabilities, social influences, and environmental context).
CONCLUSIONS
This study identifies barriers and facilitators that should be addressed when developing a complex adherence intervention tailored to patients' needs based on modifiable determinants of medication adherence, some of which are under- used by existing adherence interventions. The findings from this review will inform the design of a theory-based healthbot planned to improve varenicline adherence in people undergoing smoking cessation treatment.
SYSTEMATIC REVIEW REGISTRATION
This study was registered with PROSPERO (# CRD42022321838).
Topics: Humans; Behavior Therapy; Intention; Varenicline; Medication Adherence
PubMed: 38438884
DOI: 10.1186/s12889-024-18139-z -
CNS Spectrums Apr 2024We aim to assess the relationship between validated smoking cessation pharmacotherapies and electronic cigarettes (e-cigarettes) and insomnia and parasomnia using a... (Meta-Analysis)
Meta-Analysis Review
We aim to assess the relationship between validated smoking cessation pharmacotherapies and electronic cigarettes (e-cigarettes) and insomnia and parasomnia using a systematic review and a network meta-analysis. A systematic search was performed until August 2022 in the following databases: PUBMED, COCHRANE, CLINICALTRIAL. Randomized controlled studies against placebo or validated therapeutic smoking cessation methods and e-cigarettes in adult smokers without unstable or psychiatric comorbidity were included. The primary outcome was the presence of "insomnia" and "parasomnia." A total of 1261 studies were selected. Thirty-seven studies were included in the quantitative analysis (34 for insomnia and 23 for parasomnia). The reported interventions were varenicline (23 studies), nicotine replacement therapy (NRT, 10 studies), bupropion (15 studies). No studies on e-cigarettes were included. Bayesian analyses found that insomnia and parasomnia are more frequent with smoking cessation therapies than placebo except for bupropion. Insomnia was less frequent with nicotine substitutes but more frequent with bupropion than the over pharmacotherapies. Parasomnia are less frequent with bupropion but more frequent with varenicline than the over pharmacotherapies. Validated smoking cessation pharmacotherapies can induce sleep disturbances with different degrees of frequency. Our network meta-analysis shows a more favorable profile of nicotine substitutes for insomnia and bupropion for parasomnia. It seems essential to systematize the assessment of sleep disturbances in the initiation of smoking cessation treatment. This could help professionals to personalize the choice of treatment according to sleep parameters of each patient. Considering co-addictions, broadening the populations studied and standardizing the measurement are additional avenues for future research.
Topics: Adult; Humans; Smoking Cessation; Bupropion; Electronic Nicotine Delivery Systems; Nicotine; Varenicline; Nicotinic Agonists; Network Meta-Analysis; Sleep Initiation and Maintenance Disorders; Bayes Theorem; Tobacco Use Cessation Devices; Parasomnias
PubMed: 38433577
DOI: 10.1017/S1092852924000087 -
Psychopharmacology Apr 2024Varenicline is considered one of the most effective treatment options for smoking cessation. Nonetheless, it is only modestly effective. A deeper comprehension of the... (Review)
Review
BACKGROUND
Varenicline is considered one of the most effective treatment options for smoking cessation. Nonetheless, it is only modestly effective. A deeper comprehension of the effects of varenicline by means of the in-depth review of relevant fMRI studies may assist in paving the development of more targeted and effective treatments.
METHODOLOGY
A search of PubMed and Google Scholar databases was conducted with the keywords "functional magnetic resonance imaging" or "fMRI", and "varenicline". All peer-reviewed articles regarding the assessment of smokers with fMRI while undergoing treatment with varenicline and meeting the predefined criteria were included.
RESULTS
Several studies utilizing different methodologies and targeting different aspects of brain function were identified. During nicotine withdrawal, decreased mesocorticolimbic activity and increased amygdala activity, as well as elevated amygdala-insula and insula-default-mode-network functional connectivity are alleviated by varenicline under specific testing conditions. However, other nicotine withdrawal-induced changes, including the decreased reward responsivity of the ventral striatum, the bilateral dorsal striatum and the anterior cingulate cortex are not influenced by varenicline suggesting a task-dependent divergence in neurocircuitry activation. Under satiety, varenicline treatment is associated with diminished cue-induced activation of the ventral striatum and medial orbitofrontal cortex concomitant with reduced cravings; during the resting state, varenicline induces activation of the lateral orbitofrontal cortex and suppression of the right amygdala.
CONCLUSIONS
The current review provides important clues with regard to the neurobiological mechanism of action of varenicline and highlights promising research opportunities regarding the development of more selective and effective treatments and predictive biomarkers for treatment efficacy.
Topics: Humans; Varenicline; Smoking Cessation; Nicotine; Magnetic Resonance Imaging; Nicotinic Agonists; Brain; Substance Withdrawal Syndrome
PubMed: 38430396
DOI: 10.1007/s00213-024-06556-2 -
Korean Journal of Family Medicine Mar 2024Although major countries, such as South Korea, have developed and disseminated national smoking cessation guidelines, these efforts have been limited to developing...
Although major countries, such as South Korea, have developed and disseminated national smoking cessation guidelines, these efforts have been limited to developing individual societies or specialized institution-based recommendations. Therefore, evidence-based clinical guidelines are essential for developing smoking cessation interventions and promoting effective smoking cessation treatments. This guideline targets frontline clinical practitioners involved in a smoking cessation treatment support program implemented in 2015 with the support of the National Health Insurance Service. The Guideline Development Group of 10 multidisciplinary smoking cessation experts employed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to review recent domestic and international research and guidelines and to determine evidence levels using the GRADE methodology. The guideline panel formulated six strong recommendations and one conditional recommendation regarding pharmacotherapy choices among general and special populations (mental disorders and chronic obstructive lung disease [COPD]). Strong recommendations favor varenicline rather than a nicotine patch or bupropion, using varenicline even if they are not ready to quit, using extended pharmacotherapy (>12 weeks) rather than standard treatment (8-12 weeks), or using pharmacotherapy for individuals with mental disorders or COPD. The conditional recommendation suggests combining varenicline with a nicotine patch instead of using varenicline alone. Aligned with the Korean Society of Medicine's clinical guideline development process, this is South Korea's first domestic smoking cessation treatment guideline that follows standardized guidelines. Primarily focusing on pharmacotherapy, it can serve as a foundation for comprehensive future smoking cessation clinical guidelines, encompassing broader treatment topics beyond medications.
PubMed: 38414371
DOI: 10.4082/kjfm.23.0142