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Monaldi Archives For Chest Disease =... Dec 2023Given the increased health dangers of tobacco use, particularly in developing countries, smoking cessation intervention is crucially important. The aim of this study is...
Given the increased health dangers of tobacco use, particularly in developing countries, smoking cessation intervention is crucially important. The aim of this study is to determine and assess the effectiveness of a comprehensive smoking cessation intervention program, incorporating behavior modification, counseling, and pharmacologic treatments, in the context of the Indian scenario. The process of initiating smoking or tobacco cessation begins with the evaluation of the distinct stages that smokers undergo as part of their journey toward behavioral change. There are five different levels of preparation for quitting smoking, i.e., i) not prepared (pre-contemplation); ii) unsure (contemplation); iii) prepared (preparation); iv) action; and v) maintenance. Behavior modification and counseling are essential. The "5 A's"-based intervention uses ask, advise, assess, assist, and arrange as part of its strategy. First-line treatments such as nicotine replacement therapy, bupropion, and varenicline, as well as second-line treatments such as clonidine, cytisine, and nortriptyline, are the foundation of pharmacologic care. Every healthcare professional has a duty to help smokers stop using tobacco, and the intervention should be both therapeutic and diagnostic. Combining behavioral and social support yields the best results, along with pharmacotherapy whenever needed.
PubMed: 38050469
DOI: 10.4081/monaldi.2023.2814 -
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 -
JAMA Network Open Jun 2024Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the combination need to be evaluated.
OBJECTIVE
To examine whether hospitalized smokers treated with varenicline and NRT lozenges achieve higher prolonged smoking abstinence rates compared with those treated with varenicline alone.
DESIGN, SETTING, AND PARTICIPANTS
A double-blind, placebo-controlled randomized clinical trial was conducted in adult medical or surgical inpatients of 5 Australian public hospitals with a history of smoking 10 cigarettes or more per day, interested in quitting, and available for 12-month follow-up between May 1, 2019, and May 1, 2021 (final 12-month data collection in May 2022). Data analysis was performed from June 1 to August 30, 2023.
INTERVENTIONS
A 12-week varenicline regimen was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2 mg) or placebo lozenges if there was an urge to smoke. Behavioral support (Quitline) was offered to all participants.
MAIN OUTCOMES AND MEASURES
The primary outcome was biochemically verified sustained abstinence at 6 months. Secondary outcomes included self-reported prolonged abstinence, 7-day point prevalence abstinence (3, 6, and 12 months), and medicine-related adverse events.
RESULTS
A total of 320 participants (mean [SD] age, 52.5 [12.1] years; 183 [57.2%] male) were randomized. The conduct of biochemical verification was affected by COVID-19 restrictions; consequently, the biochemically verified abstinence in the intervention vs control arms (18 [11.4%] vs 16 [10.1%]; odds ratio [OR], 1.14; 95% CI, 0.56-2.33) did not support the combination therapy. The secondary outcomes in the intervention vs control arms of 7-day point prevalence abstinence at 6 months (54 [34.2%] vs 37 [23.4%]; OR, 1.71; 95% CI, 1.04-2.80), prolonged abstinence at 12 months (47 [29.9%] vs 30 [19.1%]; OR, 1.77; 95% CI, 1.05-3.00), and 7-day point prevalence abstinence at 12-months (48 [30.6%] vs 31 [19.7%]; OR, 1.79; 95% CI, 1.07-2.99) significantly improved with the combination therapy. The self-reported 6-month prolonged abstinence (61 [38.6%] vs 47 [29.7%]; OR, 1.49; 95% CI, 0.93-2.39) favored the combination therapy but was not statistically significant. Medicine-related adverse events were similar in the 2 groups (102 [74.5%] in the intervention group vs 86 [68.3%] in the control group).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of the combination of varenicline and NRT lozenges in hospitalized adult daily smokers, the combination treatment improved self-reported abstinence compared with varenicline alone, without compromising safety, but it did not improve biochemically validated abstinence.
TRIAL REGISTRATION
anzctr.org.au Identifier: ACTRN12618001792213.
Topics: Humans; Varenicline; Male; Female; Smoking Cessation; Tobacco Use Cessation Devices; Middle Aged; Double-Blind Method; Adult; Smoking Cessation Agents; Australia; Hospitalization; Smokers; Aged; Treatment Outcome; Nicotine Replacement Therapy
PubMed: 38935378
DOI: 10.1001/jamanetworkopen.2024.18120 -
JAMA Internal Medicine Mar 2024Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement...
IMPORTANCE
Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement therapy (NRT), and no evidence is available on how their efficacy compares with that of varenicline.
OBJECTIVE
To evaluate whether ECs are superior to NRT and noninferior to varenicline in helping smokers quit.
DESIGN, SETTING, AND PARTICIPANTS
This was a randomized clinical trial conducted at 7 sites in China and including participants who were smoking at least 10 cigarettes per day and motivated to quit, not using stop-smoking medications or EC, and willing to use any of the study products. Participants were first recruited in May 2021, and data analysis was conducted in December 2022.
INTERVENTIONS
A cartridge-based EC (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that), varenicline (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that), and 2 mg (for smokers of ≤20 cigarettes per day) or 4 mg (>20 cigarettes per day) nicotine chewing gum, all provided for 12 weeks and accompanied by minimal behavioral support (an invitation to join a self-help internet forum).
MAIN OUTCOMES AND MEASURES
The primary outcome was sustained abstinence from smoking at 6 months as validated by an expired-air carbon monoxide reading (<8 parts per million). Participants lost to follow-up were included as nonabstainers.
RESULTS
Of 1068 participants, 357 (33.5%) were female, and the mean (SD) age was 33.9 (3.1) years. A total of 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% CI, -1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the 2 other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded.
CONCLUSIONS AND RELEVANCE
The results of this randomized clinical trial found that when all treatments were provided with minimal behavior support, the efficacy of EC was noninferior to varenicline and superior to nicotine chewing gum.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2100048156.
Topics: Female; Humans; Adult; Male; Smoking Cessation; Varenicline; Nicotine Chewing Gum; Electronic Nicotine Delivery Systems; Nicotinic Agonists; Tobacco Use Cessation Devices; Smoking
PubMed: 38285562
DOI: 10.1001/jamainternmed.2023.7846 -
JMIR Formative Research Oct 2023Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied....
BACKGROUND
Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy.
OBJECTIVE
This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment.
METHODS
A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date.
RESULTS
Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments.
CONCLUSIONS
Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966.
PubMed: 37889541
DOI: 10.2196/48857 -
Frontiers in Molecular Biosciences 2024The purpose of this study is to delineate anti-inflammatory and antioxidant potential of varenicline, a cigarette smoking cessation aid, on decreasing...
The purpose of this study is to delineate anti-inflammatory and antioxidant potential of varenicline, a cigarette smoking cessation aid, on decreasing lipopolysaccharide (LPS)-elevated proinflammatory cytokines in RAW 264.7 murine macrophage cultures which we showed earlier to occur via cholinergic anti-inflammatory pathway (CAP) activation. To this end, we investigated the possible suppressive capacity of varenicline on LPS-regulated cyclooxygenase (COX-1 and COX-2) via α7 nicotinic acetylcholine receptor (α7nAChR) activation using the same model. In order to test anti-inflammatory effectiveness of varenicline, the levels of COX isoforms and products (PGE2, 6-keto PGF1α, a stable analog of PGI2, and TXA2) altered after LPS administration were determined by Enzyme Linked Immunosorbent Assay (ELISA). The antioxidant effects of varenicline were assessed by measuring reductions in reactive oxygen species (ROS) using a f intracellular a. We further investigated the contribution of nAChR subtypes by using non-selective and/or selective α7nAChR antagonists. The results were compared with that of conventional anti-inflammatory medications, such as ibuprofen, celecoxib and dexamethasone. Varenicline significantly reduced LPS-induced COX-1, COX-2 and prostaglandin levels and ROS to an extent similar to that observed with anti-inflammatory agents used. Significant downregulation in LPS-induced COX isoforms and associated decreases in PGE2, 6-keto PGF1α, and TXA2 levels along with reduction in ROS may be partly mediated via varenicline-activated α7nAChRs.
PubMed: 38859932
DOI: 10.3389/fmolb.2024.1392689 -
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 -
Tobacco Induced Diseases 2023During the pandemic, smokers who wished to access support to quit faced additional barriers. A smoking cessation service which utilized pharmacist independent...
INTRODUCTION
During the pandemic, smokers who wished to access support to quit faced additional barriers. A smoking cessation service which utilized pharmacist independent prescribers working within community pharmacy was implemented. Clients received behavioral advice via a consultation with an advisor and then three consultations with a pharmacist, who prescribed varenicline, where appropriate. Consultations were by phone or video. This evaluation assessed the self-reported outcomes and experiences of clients and pharmacists.
METHODS
A mixed-methods approach was used involving both on-line questionnaires to clients and interviews with a sample of questionnaire respondents and participating prescribing pharmacists.
RESULTS
The questionnaire was completed by 85 clients with 59% reporting they had quit. Eleven clients and seven out of eight pharmacists were interviewed. Varenicline had been received by 96% of clients. The best aspects of the service reported by clients in the questionnaire and at interview were support received from the pharmacist and ease of access to varenicline. Clients regarded the service as being 'safe' to access during the pandemic. Nearly three-quarters of client respondents (72%) stated no service improvements were required. However, national supply challenges made collection of varenicline from the nominated pharmacy an issue. Some clients experienced a long wait-time before accessing the service. For pharmacists, the service offered flexibility including the opportunity to contact clients 'out of office' hours without distractions. However, not being physically in the pharmacy could result in them not being able to access the client's medicine history. Pharmacists identified that remote consultations were not ideal for all clients.
CONCLUSIONS
Pharmacist prescribers can deliver effective smoking cessation services through remote consultations. Greater flexibility would allow the service to be tailored to the client's need.
PubMed: 37901881
DOI: 10.18332/tid/170580 -
Psychopharmacology Jul 2023Cannabis self-administration studies may be helpful for identifying factors that influence cannabis consumption and subjective response to cannabis. Additionally, these... (Review)
Review
Cannabis self-administration studies may be helpful for identifying factors that influence cannabis consumption and subjective response to cannabis. Additionally, these paradigms could be useful for testing novel pharmacotherapies for cannabis use disorder. This scoping review aims to summarize the findings from existing ad libitum cannabis self-administration studies to determine what has been learned from these studies as well as their limitations. We examined studies that specifically examined cannabis smoking, focusing on subjective response and self-administration behavior (e.g., smoking topography). A systematic search was conducted using PubMed and Embase from inception to October 22, 2022. Our search strategy identified 26 studies (total N = 662, 79% male) that met our eligibility criteria. We found that tetrahydrocannabinol (THC) concentration significantly affected subjective response to cannabis in some but not all studies. In general, cannabis self-administration tended to be most intense at the beginning of the laboratory session and decreased in later parts of the session. There was limited data on cannabis self-administration in adults older than 55. Data on external validity and test-retest reliability were also limited. Addressing these limitations in future ad libitum cannabis self-administration studies could lead to more valid and generalizable paradigms, which in turn could be used to improve our understanding of cannabis use patterns and to help guide medication development for cannabis use disorder.
Topics: Female; Humans; Male; Cannabinoid Receptor Agonists; Cannabis; Dronabinol; Hallucinogens; Marijuana Abuse; Marijuana Smoking; Reproducibility of Results
PubMed: 37157001
DOI: 10.1007/s00213-023-06360-4 -
Brain Stimulation 2023Current smoking cessation treatments are limited in terms of efficacy, particularly with regards to long term abstinence. There is a large amount of evidence implicating... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Current smoking cessation treatments are limited in terms of efficacy, particularly with regards to long term abstinence. There is a large amount of evidence implicating the insula in nicotine addiction.
OBJECTIVE
To examine the efficacy of bilateral repetitive transcranial magnetic stimulation (rTMS) directed to the insular cortex with the H11 coil, relative to sham stimulation, on smoking abstinence and smoking outcomes in smokers who are receiving standard varenicline treatment.
METHODS
This randomized, double-blind, sham controlled trial recruited 42 participants who were randomized to receive either active (n = 24) or sham (n = 18) high frequency rTMS directed to the insula (4 weeks), while receiving varenicline treatment (12 weeks). The primary outcome was 7-day point prevalence abstinence at the end of 12 weeks.
RESULTS
Smokers in the active group had significantly higher abstinence rates than those in the sham group (82.4% vs. 30.7%, p = 0.013) at the end of treatment (Week 12). Secondary outcome measures of abstinence rate at the end of rTMS treatment (Week 4), abstinence rate at 6 months, and smoking outcomes (e.g., craving, withdrawal) showed no significant differences between groups. No differences were found in adverse events reported between the groups.
CONCLUSION
This study provides evidence of the potential benefit of having a combined treatment for smoking cessation using insula rTMS with the H11 coil and varenicline. Maintenance rTMS sessions and continuation of varenicline for those in abstinence may induce longer-term effects and should be considered in future studies.
Topics: Humans; Varenicline; Smoking Cessation; Transcranial Magnetic Stimulation; Insular Cortex; Tobacco Use Disorder; Double-Blind Method; Treatment Outcome
PubMed: 37806524
DOI: 10.1016/j.brs.2023.10.002