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Nicotine & Tobacco Research : Official... Jun 2024This study aimed to (1) provide up-to-date estimates of how changes in the prevalence of e-cigarette use have been associated with changes in smoking cessation...
Associations of Prevalence of E-cigarette Use With Quit Attempts, Quit Success, Use of Smoking Cessation Medication, and the Overall Quit Rate Among Smokers in England: A Time-Series Analysis of Population Trends 2007-2022.
INTRODUCTION
This study aimed to (1) provide up-to-date estimates of how changes in the prevalence of e-cigarette use have been associated with changes in smoking cessation activities and use of licensed treatments among smokers in England and (2) explore any changes in these associations over time.
METHODS
Data were aggregated quarterly on 67 548 past-year smokers between Q1-2007 and Q4-2022. Explanatory variables were the prevalence of (1) current e-cigarette use among smokers and (2) e-cigarette use during a quit attempt. Outcomes were rates of quit attempts and overall quits among past-year smokers, and the quit success rate and use of licensed treatments among those who made a quit attempt.
RESULTS
The success rate of quit attempts increased by 0.040% (95% CI 0.019; 0.062) for every 1% increase in the prevalence of e-cigarette use during a quit attempt. No clear evidence was found for an association between current e-cigarette use and the quit attempt rate (Badj = 0.008 [95% CI -0.045; 0.061]) or overall quit rate (Badj = 0.063 [-0.031; 0.158]); or between use of e-cigarettes during a quit attempt and the overall quit rate (Badj = 0.030 [-0.054; 0.114]), use of prescription medication (varenicline/bupropion/nicotine replacement therapy [NRT]: Badj = -0.036 [-0.175; 0.102]), or use of over-the-counter NRT (Badj = -0.052 [-0.120; 0.015]). There was no clear evidence this pattern of associations has changed substantially over time.
CONCLUSIONS
Changes in the prevalence of e-cigarette use in England through 2022 have been positively associated with the success rate of quit attempts but not clearly associated with the quit attempt rate, overall quit rate, or use of licensed smoking cessation treatments.
IMPLICATIONS
If the association between the increase in e-cigarette use and the quit success rate is causal, then the use of e-cigarettes in quit attempts has helped in the region of 30 000 to 50 000 additional smokers in England to successfully quit each year since they became popular in 2013, over and above the number who were quitting before the advent of e-cigarettes.
Topics: Humans; Smoking Cessation; England; Electronic Nicotine Delivery Systems; Female; Male; Adult; Prevalence; Middle Aged; Vaping; Smokers; Young Adult; Smoking Cessation Agents; Adolescent; Tobacco Use Cessation Devices; Aged
PubMed: 38214664
DOI: 10.1093/ntr/ntae007 -
PloS One 2024Alcohol Use Disorder (AUD) is a major cause of premature death, disability and suffering. Available treatments are of modest efficacy and under-prescribed so there is a...
A randomized, double-blind, placebo-controlled, multicentre trial on the efficacy of varenicline and bupropion in combination and alone for treatment of alcohol use disorder: Protocol for the COMB study.
BACKGROUND
Alcohol Use Disorder (AUD) is a major cause of premature death, disability and suffering. Available treatments are of modest efficacy and under-prescribed so there is a pressing need for a well-tolerated and effective treatment option for AUD. Dopamine is hypothesized to be involved in the development of alcohol dependence. To challenge the low-dopamine hypothesis of addiction, this randomized, double-blind, placebo-controlled, 13-week, multicentre clinical trial with four parallel arms is designed to evaluate the efficacy of two substances raising dopamine levels, varenicline and bupropion, alone and in combination vs. placebo on alcohol consumption in AUD. Varenicline, a partial agonist at brain nicotinic acetylcholine receptors increases dopamine release, whereas bupropion is a centrally-acting, norepinephrine-dopamine reuptake inhibitor. Varenicline is previously shown to reduce alcohol intake in individuals with AUD. We hypothesize that the effect size of a combination of two drugs affecting dopamine levels in the brain will exceed that of approved AUD therapies.
METHODS
Consenting individuals with AUD will be recruited via media advertisements. Those fulfilling the eligibility criteria (N = 380) will be randomized to one of four interventions (n = 95 per arm). Treatment will comprise one week of titration (varenicline 0.5‒2 mg; bupropion SR 150‒300 mg) plus 12 weeks at steady state. Efficacy will be evaluated using two primary endpoints of alcohol consumption: Heavy Drinking Days and blood levels of phosphatidylethanol. Secondary objectives, exploratory and subgroup analyses will be also performed. The modified Intention-to-Treat and Per Protocol datasets will be evaluated using Analysis of Covariance. Last patient out is estimated to occur in December, 2022.
DISCUSSION
The COMB Study aims to evaluate the efficacy of the combination of varenicline and bupropion, two drugs affecting dopamine, on alcohol consumption, and to challenge the low-dopamine hypothesis of addiction. Study Code COMB-BO8, EudraCT 2018-000048-24, Version 3.2, Lidö & deBejczy, 2020-06-16; https://clinicaltrials.gov identifier NCT04167306.
Topics: Humans; Varenicline; Bupropion; Alcoholism; Nicotinic Agonists; Dopamine; Smoking Cessation; Benzazepines; Quinoxalines; Treatment Outcome; Alcohol Drinking; Double-Blind Method; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 38206930
DOI: 10.1371/journal.pone.0296118 -
EClinicalMedicine Dec 2023The efficacy and safety of varenicline for smoking cessation among individuals who smoke tobacco cigarettes and also use electronic cigarettes (known e-cigarettes or...
BACKGROUND
The efficacy and safety of varenicline for smoking cessation among individuals who smoke tobacco cigarettes and also use electronic cigarettes (known e-cigarettes or vapes) have not been studied. We aimed to address this knowledge gap and examine predictors for smoking abstinence.
METHODS
In this double-blind, placebo-controlled, single-centre randomised trial in Italy, we enrolled adults who had used an e-cigarette daily for at least 12 months and who also smoked at least one tobacco cigarette per day and had a willingness to quit smoking. 155 participants were randomly assigned to receive either varenicline (n = 78) or matched placebo (n = 77). Varenicline (1 mg, administered twice daily for 12 weeks) was given in combination with smoking cessation counseling in dual users with an intention to quit smoking. Participants in both treatment groups received the same smoking cessation counselling throughout the whole duration of the study. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up. The primary efficacy endpoint was continuous abstinence rate (CAR) in weeks 4-12. Secondary efficacy endpoints were the CAR in weeks 4-24 and 7-day point prevalence of smoking abstinence at weeks 12 and 24. This study is registered in EUDRACT, 2016-000339-42.
FINDINGS
Between November 2018, and February 2020, 114 participants (61 in the varenicline group and 53 in the placebo group) completed the intervention phase at week 12 and 88 participants (52 in the varenicline group and 36 in the placebo group) completed the follow-up phase at week 24. CARs were significantly higher for the varenicline vs placebo at each time-point: 50.0% vs 16.9% (OR = 4.9; 95% CI, 2.3-10.4; P < 0.0001) between weeks 4 and 12; and 48.7% vs 14.3% (OR = 5.7; 95% CI, 2.6-12.3; P < 0.0001) between weeks 4 and 24. The 7-day point prevalence of smoking abstinence was also higher for the varenicline than placebo at each time point. Adverse events were rated as mild or moderate and rarely led to treatment discontinuation.
INTERPRETATION
Our findings indicate that inclusion of varenicline in a cessation programme for adults who smoke and use e-cigarettes with an intention to quit smoking could result in smoking abstinence without serious adverse events. In the absence of evidence from other smoking cessation methods, it could be useful to suggest the use of varenicline in cessation programmes specifically designed to help dual users stop smoking. Further research in larger and more generalisable populations is required to strengthen such a suggestion.
FUNDING
Global Research Award for Nicotine Dependence, an independently reviewed competitive grants programmeme funded by Pfizer.
PubMed: 38192585
DOI: 10.1016/j.eclinm.2023.102316 -
Tumori Apr 2024Cigarette smoke accounts for over 90,000 deaths each year in Italy. Tobacco dependence treatment guidelines suggest adopting an integrated pharmacological-behavioral... (Observational Study)
Observational Study
INTRODUCTION
Cigarette smoke accounts for over 90,000 deaths each year in Italy. Tobacco dependence treatment guidelines suggest adopting an integrated pharmacological-behavioral model of intervention. Cytisine is a partial agonist of nicotinic receptors. Trials conducted to date have demonstrated its good efficacy in promoting smoking cessation. The cytisine scheme of treatment consists of 25 days of treatment. A 40-day regimen, with an escalating dose and an extended duration of the treatment, has been in use in many anti-smoking centers in Italy for several years, but to date there are no reports on the use of cytisine with this scheme.
METHODS
A retrospective, real-life, observational study was conducted between January 2016 and September 2022. The 300 patients who had received at least one dose of study medication were selected. Continuous variables were compared by the Wilcoxon-Mann-Whitney test. Univariate and multivariate logistic regression models were implemented for self-reported seven-day point prevalence for abstinence at three, six and 12 months.
RESULTS
The median age of the patients was 59 years, 57% were women. The median smoking exposure was 33.8 pack-years. Self-reported smoking abstinence at three, six and 12 months was 68.7%, 56.3% and 47.3% respectively. 84% completed the cytisine treatment, 31.3% reported adverse events and in 8.3% these led to dropping out of the treatment.
CONCLUSION
Cytisine, administered with a novel therapeutic scheme in the real-life setting of a specialized anti-smoking center, significantly promotes smoking abstinence. However, more studies are needed to assess the tolerability and efficacy of this new regimen.
Topics: Humans; Female; Middle Aged; Male; Smoking Cessation; Varenicline; Nicotinic Agonists; Benzazepines; Retrospective Studies; Quinoxalines; Alkaloids; Azocines; Quinolizines; Quinolizidine Alkaloids
PubMed: 38149659
DOI: 10.1177/03008916231216906 -
Journal of Clinical Medicine Dec 2023Tobacco smoking has been a recognized risk factor for cardiovascular diseases (CVD). Smoking is a chronic relapsing disease and pharmacotherapy is a main component of... (Review)
Review
Tobacco smoking has been a recognized risk factor for cardiovascular diseases (CVD). Smoking is a chronic relapsing disease and pharmacotherapy is a main component of smoking cessation. Obstructive sleep apnea (OSA) and smoking both increase the risk of CVD and are associated with significant morbidity and mortality. There are few existing data examining how pharmacological treatment, such as nicotine replacement therapy (NRT), bupropion, and varenicline, affect smokers suffering with OSA and especially their cardiovascular effects. The aim of this review was to evaluate the effects of smoking cessation pharmacotherapy on OSA with a special emphasis on the cardiovascular system. Results: Only small studies have assessed the effect of NRTs on OSA. Nicotine gum administration showed an improvement in respiratory events but with no permanent results. No specific studies were found on the effect of bupropion on OSA, and a limited number evaluated varenicline's effects on sleep and specifically OSA. Varenicline administration in smokers suffering from OSA reduced the obstructive respiratory events, especially during REM. Studies on second-line medication (nortriptyline, clonidine, cytisine) are even more limited. There are still no studies evaluating the cardiovascular effects of smoking cessation medications on OSA patients. Conclusions: Sleep disturbances are common withdrawal effects during smoking cessation but could be also attributed to pharmacotherapy. Smokers should receive personalized treatment during their quitting attempts according to their individual needs and problems, including OSA. Future studies are needed in order to evaluate the efficacy and safety of smoking cessation medications in OSA patients.
PubMed: 38137639
DOI: 10.3390/jcm12247570 -
Brain Sciences Dec 2023Social anxiety disorder (SAD) is a debilitating psychiatric condition. Consequently, it is common for those affected to resort to cannabis to cope with their symptoms....
Social anxiety disorder (SAD) is a debilitating psychiatric condition. Consequently, it is common for those affected to resort to cannabis to cope with their symptoms. The primary objective of this study was to understand the differences between motivations for cannabis use in adults with and without SAD. We employed convergent, mixed methods to collect the data. Twenty-six individuals (age: 27.9 ± 7.3 years; 54% female) with and twenty-six (age: 27.4 ± 6.7 years; 50% female) without SAD were administered Marijuana Motives Measure (MMM). Motivations to initiate, continue, and maintain cannabis use were assessed in 12/26 participants in both groups using in-depth interviews. Cannabis weekly consumption was 3.8-fold and frequency 1.3-fold higher in the SAD group. Coping (F = 10.02; <0.001; η = 0.46) and social (F = 2.81; = 0.036; η = 0.19) motivations were also higher in the SAD group, after controlling for age, sex, and current CUD. The need to cope with symptoms of SAD may have been the driving force for repeated cannabis consumption. Psychoeducational programs educating children about the risk of using cannabis to cope with SAD should be implemented in vocational settings early on.
PubMed: 38137146
DOI: 10.3390/brainsci13121698 -
BMC Medicine Dec 2023Studies conducted during the early stages of the pandemic documented mixed changes in smoking behaviour: more smokers quitting successfully but little change in...
Have there been sustained impacts of the COVID-19 pandemic on trends in smoking prevalence, uptake, quitting, use of treatment, and relapse? A monthly population study in England, 2017-2022.
BACKGROUND
Studies conducted during the early stages of the pandemic documented mixed changes in smoking behaviour: more smokers quitting successfully but little change in prevalence. This study aimed to examine whether there have been sustained impacts of the COVID-19 pandemic on smoking patterns in England.
METHODS
Data were from 101,960 adults (≥ 18 years) participating in the Smoking Toolkit Study, a monthly representative household survey, between June 2017 and August 2022. Interviews were conducted face-to-face until March 2020 and via telephone thereafter. Generalised additive models estimated associations of the pandemic onset (March 2020) with current smoking, uptake, cessation, quit attempts, and use of support. Models adjusted for seasonality, sociodemographic characteristics, and (where relevant) dependence and tobacco control mass-media expenditure.
RESULTS
Before the COVID-19 pandemic, smoking prevalence fell by 5.2% per year; this rate of decline slowed to 0.3% per year during the pandemic (RR = 1.06, 95% CI = 1.02, 1.09). This slowing was evident in more but not less advantaged social grades (RR = 1.15, 1.08, 1.21; RR = 1.00, 0.96, 1.05). There were sustained step-level changes in different age groups: a 34.9% (95% CI = 17.7, 54.7%) increase in smoking prevalence among 18-24-year-olds, indicating a potential rise in uptake, in contrast to a 13.6% (95% CI = 4.4, 21.9%) decrease among 45-65-year-olds. In both age groups, these step-level changes were followed by the pre-pandemic declines stopping, and prevalence remaining flat. There were sustained increases in quitting among past-year smokers, with a 120.4% (95% CI = 79.4, 170.9%) step-level increase in cessation and a 41.7% (95% CI = 29.7, 54.7%) increase in quit attempts. The main limitation was the change in modality of data collection when the pandemic started; while this may have contributed to the step-level changes we observed, it is unlikely to explain changes in the slope of trends.
CONCLUSIONS
In England, the rate of decline in adult smoking prevalence stagnated during the COVID-19 pandemic through to 2022. At the start of the pandemic, a potential reduction in smoking prevalence among middle-aged adults and increases in quitting among smokers may have been offset by an increase in smoking among young adults. The slowing in the rate of decline was pronounced in more advantaged social grades.
Topics: Young Adult; Middle Aged; Humans; Adult; Smoking Cessation; Pandemics; Prevalence; Cross-Sectional Studies; COVID-19; Smoking; England; Recurrence
PubMed: 38093317
DOI: 10.1186/s12916-023-03157-2 -
JMIR Research Protocols Dec 2023Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline...
BACKGROUND
Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes.
OBJECTIVE
This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial.
METHODS
We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use "stop, amend, and go" progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method.
RESULTS
Participant enrollment for the study will begin in January 2024.
CONCLUSIONS
By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/53556.
PubMed: 38079201
DOI: 10.2196/53556 -
Contact Lens & Anterior Eye : the... Feb 2024To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED). (Review)
Review
PURPOSE
To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED).
METHODS
A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected.
RESULTS
A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of -7.5 ± 2.2 points [-11.6 to -5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of -1.2 ± 0.01 points [-1.2 to -1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %.
CONCLUSIONS
OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.
Topics: Humans; Dry Eye Syndromes; Fluorescein; Nasal Sprays; Tears; Varenicline
PubMed: 38065797
DOI: 10.1016/j.clae.2023.102097 -
International Journal of Chronic... 2023Cigarette smoke exposure is the main preventable cause of chronic obstructive pulmonary disease (COPD). Airflow limitation is closely associated with smoking exposure....
BACKGROUND
Cigarette smoke exposure is the main preventable cause of chronic obstructive pulmonary disease (COPD). Airflow limitation is closely associated with smoking exposure. Smoking could also interfere with lipid metabolism.
AIM
To determine the respiratory functional and metabolic changes after smoking cessation in smokers in the short term.
METHODS
All patients were current smokers. They were assessed by spirometry and questionnaires such as COPD assessment test(CAT), modified Medical Research Council (mMRC) test for dyspnea, Fagestrom's test for nicotine dependence. Exhaled CO was detected in order to evaluate smoking exposure and smoking cessation (normal value<7 ppm). A blood sampling was eventually taken for vitamin D and cholesterol assay. All patients underwent therapy with counselling and varenicline as first-line treatment according to its schedule. Detection time: at baseline and one month after smoking cessation.
RESULTS
All patients quit smoking during treatment. The mean age was 62 with a prevalence of males. The analysis revealed the following mean values at baseline: CAT mean score was 15, pack-years 35.5, Fagestrom's Test mean score 5.0. The West's value was 8.5, whereas Body mass index (BMI) was 25.5.Cigarette daily consumption mean value was 22.5. The comparison before and at follow up one month after smoking cessation about functional and metabolic parameters, show us the following results: FEV 1 was increased by 200 mL (p<0.02), FEF 25/75 was improved as well as mMRC test. The eCO was dropped to as low as 8 ppM. Interestingly the vitamin D level was increased from 25 to 28 ng/mL without any support therapy. The cholesterol total level was reduced and CAT value and DLCO were also significantly improved.
CONCLUSION
Quit smoking is useful to improve symptoms, respiratory function and metabolic parameters in the short term.
Topics: Male; Humans; Middle Aged; Female; Pulmonary Disease, Chronic Obstructive; Smoking Cessation; Smokers; Cholesterol; Vitamin D
PubMed: 38059013
DOI: 10.2147/COPD.S423148