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1.
BMC Oral Health ; 24(1): 889, 2024 Aug 03.
Article in English | MEDLINE | ID: mdl-39097712

ABSTRACT

BACKGROUND: Increase in nicotine pouch (NP) users, particularly among the young, is a matter of concern requiring a comprehensive understanding of its short- and long-term oral health implications. The objective of this research was to systematically review potential oral side-effects associated with NP usage. METHODS: This systematic review was conducted following the PRISMA guidelines. Databases (Medline via PubMed, Scopus, Cochrane Trial, and Google Scholar) were searched for relevant studies up to February 2024. Modified Newcastle-Ottawa Scale (NOS) and the Risk Of Bias In Non-randomized Studies - of Exposure (ROBINS-E) tool were used to assess the quality and bias of the included studies. RESULTS: Three studies were included for this review, two from Europe and one from USA, and considered of a total of 190 participants. All studies were deemed to have a high risk of bias. Participants used NP for periods ranging from 1 month to 10 years. Among these studies, only one study provided information on the usage pattern between 1 and 5 units for an average of 11 ± 7 min per session. Oral mucosal changes at the site of placement were common among NP users. Oral lesions varied from slight wrinkling to various white lesions, seemingly related to the NP units consumed per day and their duration of usage. Other oral side effects included dry mouth, soreness, gingival blisters, and a strange jaw sensation. CONCLUSIONS: Research on the use of NP and its effect on oral health are currently limited. The use of NP should take into consideration the short-and-long-term effects, especially on oral health. Further studies are crucial to understand oral health implications associated with NP usage. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Registration number CRD 42,024,500,711.


Subject(s)
Oral Health , Humans , Tobacco Use Cessation Devices/adverse effects , Nicotine/adverse effects , Mouth Diseases/chemically induced
7.
Psychiatry Res ; 335: 115874, 2024 May.
Article in English | MEDLINE | ID: mdl-38564922

ABSTRACT

Smoking cessation medications have the potential to affect the functioning of the nervous system, leading to sleep disturbances. Our study aimed to compare the sleep-related side effects (such as insomnia, abnormal dreams, nightmares, and somnolence) induced by different smoking cessation medications in non-psychiatric smokers. We conducted a thorough search of five electronic databases (Cochrane, EMBASE, PubMed, PsycInfo, and Web of Science) for randomized controlled trials. This study was registered with the PROSPERO (registration number CRD42022347976). A total of 79 full-text articles, encompassing 36,731 participants, were included in our analysis. Individuals using bupropion, bupropion in combination with a nicotinic acetylcholine receptor agonist (NRA), and bupropion in conjunction with nicotine replacement therapy (NRT) exhibited a higher likelihood of experiencing insomnia compared to those using NRT alone. Bupropion plus NRA had the highest ranking on the surface under the cumulative ranking curve (SUCRA) for insomnia risk, while placebo had the lowest ranking. Additionally, NRA plus NRT ranked first for abnormal dream outcomes, NRA alone for nightmares, and nortriptyline for somnolence, based on the SUCRA results. Healthcare providers should exercise caution when prescribing smoking cessation drugs, particularly in consideration of their potential sleep-related side effects.


Subject(s)
Sleep Initiation and Maintenance Disorders , Smoking Cessation , Humans , Smoking Cessation/psychology , Bupropion/adverse effects , Varenicline/therapeutic use , Smoking/psychology , Network Meta-Analysis , Sleep Initiation and Maintenance Disorders/drug therapy , Sleepiness , Tobacco Use Cessation Devices/adverse effects , Randomized Controlled Trials as Topic , Nicotinic Agonists/adverse effects , Sleep
8.
Clin Pharmacol Ther ; 116(1): 128-135, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38529793

ABSTRACT

Transdermal nicotine patches (TNPs), administering nicotine into the bloodstream through skin, have been widely used as nicotine replacement therapy, and exposure to nicotine can be detected by measurement of plasma cotinine concentration. In animal studies, nicotine treatment could increase the number of endothelial progenitor cells (EPCs), but the effect of TNPs on circulating EPCs and their activity in humans remained unclear. This study aimed to explore the influence of TNPs on circulating EPCs with surface markers of CD34, CD133, and/or KDR, and colony-forming function plus migration activity of early EPCs derived from cultured peripheral blood mononuclear cells before and after TNP treatments in young healthy nonsmokers. In parallel, pulse wave analysis (PWA) was applied to evaluate the vascular effect of TNP treatments. Twenty-one participants (25.8 ± 3.6 years old, 10 males) used TNP (nicotine: 4.2 mg/day) for 7 consecutive days. During the treatment, the CD34+ EPCs progressively increased in number. In addition, the number of EPCs positive for CD34/KDR, CD133, and CD34/CD133 were also increased on day 7 of the treatment. Furthermore, the early EPC colony-forming function and migration activity were increased with the plasma cotinine level positively correlating with change in colony-forming unit number. PWA analyses on day 7, compared with pretreatment, did not show significant change except diastolic pressure time index, which was prolonged and implied potential vascular benefit. In conclusion, 7-day TNP treatments could be a practical strategy to enhance angiogenesis of circulating EPCs to alleviate tissue ischemia without any hemodynamic concern.


Subject(s)
Cell Movement , Cotinine , Endothelial Progenitor Cells , Hemodynamics , Nicotine , Transdermal Patch , Humans , Endothelial Progenitor Cells/drug effects , Endothelial Progenitor Cells/metabolism , Male , Adult , Nicotine/administration & dosage , Nicotine/blood , Female , Young Adult , Cotinine/blood , Cell Movement/drug effects , Hemodynamics/drug effects , Non-Smokers , Cells, Cultured , Pulse Wave Analysis , Tobacco Use Cessation Devices/adverse effects , Administration, Cutaneous
9.
N Engl J Med ; 390(7): 601-610, 2024 Feb 15.
Article in English | MEDLINE | ID: mdl-38354139

ABSTRACT

BACKGROUND: Electronic nicotine-delivery systems - also called e-cigarettes - are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of these systems is needed. METHODS: In this open-label, controlled trial, we randomly assigned adults who were smoking at least five tobacco cigarettes per day and who wanted to set a quit date to an intervention group, which received free e-cigarettes and e-liquids, standard-of-care smoking-cessation counseling, and optional (not free) nicotine-replacement therapy, or to a control group, which received standard counseling and a voucher, which they could use for any purpose, including nicotine-replacement therapy. The primary outcome was biochemically validated, continuous abstinence from smoking at 6 months. Secondary outcomes included participant-reported abstinence from tobacco and from any nicotine (including smoking, e-cigarettes, and nicotine-replacement therapy) at 6 months, respiratory symptoms, and serious adverse events. RESULTS: A total of 1246 participants underwent randomization; 622 participants were assigned to the intervention group, and 624 to the control group. The percentage of participants with validated continuous abstinence from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (relative risk, 1.77; 95% confidence interval, 1.43 to 2.20). The percentage of participants who abstained from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group, but the percentage who abstained from any nicotine use was 20.1% in the intervention group and 33.7% in the control group. Serious adverse events occurred in 25 participants (4.0%) in the intervention group and in 31 (5.0%) in the control group; adverse events occurred in 272 participants (43.7%) and 229 participants (36.7%), respectively. CONCLUSIONS: The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking-cessation counseling alone. (Funded by the Swiss National Science Foundation and others; ESTxENDS ClinicalTrials.gov number, NCT03589989.).


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Adult , Humans , Nicotine/administration & dosage , Nicotine/adverse effects , Smoking Cessation/methods , Tobacco Use Cessation Devices/adverse effects
10.
Nicotine Tob Res ; 26(1): 31-38, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-37474127

ABSTRACT

INTRODUCTION: This study sought to compare medication efficacy in participants with medical comorbidities who smoke in the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial, a double-blind, triple-dummy, placebo- and active-controlled randomized controlled trial. AIMS AND METHODS: Participants were from the U.S. cohort of the main trial and randomized (1:1:1:1) to varenicline, bupropion, nicotine replacement therapy (NRT) patch, or placebo for 12 weeks with follow-up through week 24. Medical comorbidity data were derived from the baseline medical screening questionnaire and categorized into four subgroups (cardiac, respiratory, vascular, and diabetes). Within each comorbidity, generalized linear mixed models were used to assess the association between treatment and continuous abstinence rates from weeks 9-12 to 9-24. Similar models were used to test the effect of number of comorbidities on abstinence. RESULTS: Varenicline resulted in the highest week 12 abstinence rates across all pharmacotherapies and compared to placebo in all comorbidity subgroups: Cardiac (40.0% vs. 3.6%; odds ratios [OR] = 23.3 [5.1-107.1]), respiratory (24.7% vs. 12.8%; OR = 2.2 [1.3-3.8]), vascular (29.1% vs. 10.4%; OR = 3.6 [2.3-5.7]), and diabetes (30.9% vs. 8.3%; OR = 6.5 [2.3-19.0]). This was maintained at week 24 for those with cardiac (23.3% vs. 1.8%; OR = 21.7 [2.7-178.2]), vascular (18.9% vs. 7.1%; OR = 3.1 [1.8-5.3]), and diabetes (20.6% vs. 4.2%; OR = 8.4 [2.1-33.7]) comorbidities. Treatment contrasts within some comorbidity subgroups revealed superior efficacy of varenicline over other pharmacotherapies. All pharmacotherapies increased the odds of abstinence regardless of number of comorbidities. CONCLUSIONS: Varenicline is the most efficacious option for patients with manageable cardiac, respiratory, vascular, and diabetes conditions to quit smoking, supporting recent clinical practice guidelines that recommend varenicline as first-line pharmacotherapy. Bupropion and NRT demonstrated efficacy for some comorbidity subgroups. IMPLICATIONS: This secondary analysis of the EAGLES trial demonstrated that varenicline is the most efficacious option for patients with cardiac, respiratory, vascular, and diabetes diagnoses to quit smoking. This demonstration of varenicline efficacy among individuals with comorbid medical conditions supports recent clinical practice guidelines that recommend varenicline as a first-line pharmacotherapy for smoking cessation.


Subject(s)
Diabetes Mellitus , Smoking Cessation , Humans , Smoking Cessation/methods , Varenicline , Bupropion/adverse effects , Nicotinic Agonists/therapeutic use , Tobacco Use Cessation Devices/adverse effects , Comorbidity , Diabetes Mellitus/chemically induced , Diabetes Mellitus/drug therapy , Treatment Outcome , Benzazepines/therapeutic use , Quinoxalines/therapeutic use
11.
J Subst Use Addict Treat ; 160: 209286, 2024 May.
Article in English | MEDLINE | ID: mdl-38160877

ABSTRACT

INTRODUCTION: The frequency with which people change from one medical treatment to another partly reflects satisfaction with the initial intervention. In this secondary analysis of observational data, we explore switch rates for short-acting nicotine replacement therapy (NRT) products, which differ in mode of use, rapidity of action, and adverse effect profiles. METHODS: We analyzed data from 46,882 participants in the Smoking Treatment for Ontario Patients program who received short-acting NRT (gum, lozenge, oral spray, or inhaler) at their initial visit. We used discrete-time survival analysis to model the time elapsing before a change was made to another product and included time-by-product interactions to explore differences over time and product-by-previous-quit-attempts interactions to examine the importance of potential previous exposure to NRT. We adjusted both models for a range of sociodemographic and tobacco use variables. RESULTS: Overall, 37.9% (95% CI = 37.5%, 38.4%) of participants switched to a different product at their first follow-up visit. Time-averaged and adjusted switch probabilities were 21.1% for gum, 23.8% for lozenge, 26.0% for inhaler, and 28.8% for oral spray. Switch rates were highest for people without past quit attempts, for women, and for people also using the nicotine patch. CONCLUSIONS: People frequently switch from one type of short-acting NRT to another. We did not assess reasons for switching, but they may include adverse effects, impracticality, and perceived ineffectiveness. Given the superior effectiveness of combination treatment, making multiple products available may improve outcomes by allowing some people to continue with short-acting products for longer.


Subject(s)
Smoking Cessation , Tobacco Use Cessation Devices , Humans , Female , Male , Tobacco Use Cessation Devices/adverse effects , Middle Aged , Adult , Smoking Cessation/methods , Ontario , Nicotine/administration & dosage , Nicotine/adverse effects , Nicotine Replacement Therapy
12.
Drug Alcohol Rev ; 42(5): 1278-1287, 2023 07.
Article in English | MEDLINE | ID: mdl-37132177

ABSTRACT

ISSUES: Established literature suggests that electronic cigarettes (EC) are more effective than traditional nicotine replacement therapies (NRT) as a smoking cessation aid, but the factors that mediate this difference remain poorly understood. We examine how adverse events (AE) associated with EC use relative to NRTs differ, with the view that differences in AEs experienced may drive differences in use and compliance. APPROACH: Papers for inclusion were identified via a three-tiered search strategy. Eligible articles involved healthy participants and compared nicotine ECs to non-nicotine ECs or NRTs and reported frequency of AE as an outcome. Random-effects meta-analyses were conducted to compare the likelihood for each of the AEs between nicotine ECs, non-nicotine placebo ECs and NRTs. KEY FINDINGS: A total of 3756 papers were identified, of which 18 were meta-analysed (10 cross-sectional and 8 randomised controlled trials). Meta-analytic results found no significant difference in the rates of reported AEs (i.e., cough, oral irritation, nausea) between nicotine ECs and NRTs, and between nicotine and non-nicotine placebo ECs. IMPLICATIONS: The variation in the incidence of AEs likely does not explain user preferences of ECs to NRTs. Incidence of common AEs reported because of EC and NRT use did not differ significantly. Future work will need to quantify both the adverse and favourable effects of ECs to understand the experiential mechanisms that drive the high uptake of nicotine ECs relative to established NRTs. CONCLUSIONS: There is inconclusive evidence on the incidence of AEs experience when using ECs compared to NRTs, possibly given the small sample size of studies.


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Humans , Smoking Cessation/methods , Nicotinic Agonists/therapeutic use , Cross-Sectional Studies , Tobacco Use Cessation Devices/adverse effects , Nicotine/adverse effects
13.
Trials ; 24(1): 251, 2023 Apr 01.
Article in English | MEDLINE | ID: mdl-37005655

ABSTRACT

BACKGROUND: Women experience greater difficulty achieving smoking abstinence compared to men. Recent evidence suggests that hormonal fluctuations during different phases of the menstrual cycle can contribute to lower smoking abstinence rates following a quit attempt among women. However, these findings are limited by small sample sizes and variability among targeted smoking quit dates. This clinical trial aims to clarify whether targeting the quit date to the follicular or luteal phase of the menstrual cycle can improve smoking abstinence. METHODS: Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. We will randomize 1200 eligible individuals to set a target quit date: (1) during the mid-luteal phase, (2) during the mid-follicular phase, or (3) 15-30 days after enrollment with no regard to the menstrual cycle phase (usual practice). Participants will receive a 6-week supply of combination NRT consisting of a nicotine patch plus their choice of nicotine gum or lozenge. Participants will be instructed to start using NRT on their target quit date. Optional behavioral support will consist of a free downloadable app and brief videos focusing on building a quit plan, coping with cravings, and relapse prevention, delivered via e-mail. Smoking status will be assessed via dried blood spot analysis of cotinine concentration at 7 days, 6 weeks, and 6 months post-target quit date. DISCUSSION: We aim to overcome the limitations of previous studies by recruiting a large sample of participants and assigning target quit dates to the middle of both the follicular and luteal phases. The results of the trial can further elucidate the effects of the menstrual cycle on smoking cessation outcomes and whether it is beneficial to combine menstrual cycle phase timing strategies with accessible and low-cost NRT. TRIAL REGISTRATION: ClinicalTrials.gov NCT05515354. Registered on August 23, 2022.


Subject(s)
Smoking Cessation , Male , Humans , Female , Smoking Cessation/methods , Nicotine , Tobacco Use Cessation Devices/adverse effects , Smoking/therapy , Menstrual Cycle , Smoking Prevention/methods , Randomized Controlled Trials as Topic
14.
Heart ; 109(13): 1016-1024, 2023 06 14.
Article in English | MEDLINE | ID: mdl-36878673

ABSTRACT

OBJECTIVE: To determine the comparative effectiveness of postdischarge use of varenicline versus prescription nicotine replacement therapy (NRT) patches for the prevention of recurrent cardiovascular events and mortality and whether this association differs by sex. METHODS: Our cohort study used routinely collected hospital, pharmaceutical dispensing and mortality data for residents of New South Wales, Australia. We included patients hospitalised for a major cardiovascular event or procedure 2011-2017, who were dispensed varenicline or prescription NRT patches within 90day postdischarge. Exposure was defined using an approach analogous to intention to treat. Using inverse probability of treatment weighting with propensity scores to account for confounding, we estimated adjusted HRs for major cardiovascular events (MACEs), overall and by sex. We fitted an additional model with a sex-treatment interaction term to determine if treatment effects differed between males and females. RESULTS: Our cohort of 844 varenicline users (72% male, 75% <65 years) and 2446 prescription NRT patch users (67% male, 65% <65 years) were followed for a median of 2.93 years and 2.34 years, respectively. After weighting, there was no difference in risk of MACE for varenicline relative to prescription NRT patches (aHR 0.99, 95% CI 0.82 to 1.19). We found no difference (interaction p=0.098) between males (aHR 0.92, 95% CI 0.73 to 1.16) and females (aHR 1.30, 95% CI 0.92 to 1.84), although the effect among females deviated from the null. CONCLUSION: We found no difference between varenicline and prescription NRT patches in the risk of recurrent MACE. These results should be considered when determining the most appropriate choice of smoking cessation pharmacotherapy.


Subject(s)
Cardiovascular Diseases , Smoking Cessation , Tobacco Use Cessation Devices , Varenicline , Female , Humans , Male , Aftercare , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/chemically induced , Cohort Studies , Nicotine/adverse effects , Nicotinic Agonists/adverse effects , Patient Discharge , Smoking Cessation/methods , Tobacco Use Cessation Devices/adverse effects , Varenicline/adverse effects
15.
Nicotine Tob Res ; 25(7): 1310-1318, 2023 Jun 09.
Article in English | MEDLINE | ID: mdl-36861351

ABSTRACT

INTRODUCTION: Improving adherence to nicotine replacement therapy (NRT) in pregnancy may result in higher smoking cessation rates. Informed by the Necessities and Concerns Framework, we developed an intervention targeting pregnancy NRT adherence. To evaluate this, we derived the NRT in pregnancy necessities and concerns questionnaire (NiP-NCQ), which measures perceived need for NRT and concerns about potential consequences. AIMS AND METHODS: Here we describe the development and content validation of NiP-NCQ. From qualitative work, we identified potentially modifiable determinants of pregnancy NRT adherence and classed these as necessity beliefs or concerns. We translated these into draft self-report items and piloted items on 39 pregnant women offered NRT and a prototype NRT adherence intervention, assessing distributions and sensitivity to change. After removing poorly performing items, smoking cessation experts (N = 16) completed an online discriminant content validation (DCV) task to determine whether retained items measure a necessity belief, concern, both, or neither construct. RESULTS: Draft NRT concern items encompassed safety for the baby, side effects, too much or insufficient nicotine, and addictiveness. Draft necessity belief items included perceived need for NRT for short- and longer-term abstinence, and desire to minimize or cope without NRT. Of 22 out of 29 items retained after piloting, four were removed following the DCV task: three were judged to measure neither construct and one possibly both. The final NiP-NCQ comprised nine items per construct (18 total). CONCLUSIONS: The NiP-NCQ measures potentially modifiable determinants of pregnancy NRT adherence within two distinct constructs and may have research and clinical utility for evaluating interventions targeting these. IMPLICATIONS: Poor adherence to NRT in pregnancy may result from low perceived need and concerns about consequences; interventions challenging these beliefs may yield higher smoking cessation rates. To evaluate an NRT adherence intervention informed by the Necessities and Concerns Framework, we developed the NiP-NCQ. Through the content development and refinement processes described in this paper, we derived an evidence-based, 18-item questionnaire measuring two distinct constructs within two nine-item subscales. Higher concerns and lower necessity beliefs indicate more negative NRT beliefs; NiP-NCQ may have research and clinical utility for interventions targeting these.


Subject(s)
Smoking Cessation , Pregnancy , Female , Humans , Tobacco Use Cessation Devices/adverse effects , Nicotine/therapeutic use , Pregnant Women , Self Report
16.
Eur Respir Rev ; 32(167)2023 Mar 31.
Article in English | MEDLINE | ID: mdl-36948500

ABSTRACT

A significant proportion of COPD patients (∼40%) continue smoking despite knowing that they have the disease. Smokers with COPD exhibit higher levels of nicotine dependence, and have lower self-efficacy and self-esteem, which affects their ability to quit smoking. Treatment should be adapted to the needs of individual patients with different levels of tobacco dependence. The combination of counselling plus pharmacotherapy is the most effective cessation treatment for COPD. In patients with severe COPD, varenicline and bupropion have been shown to have the highest abstinence rates compared with nicotine replacement therapy. There is a lack of evidence to support that smoking cessation reduction or harm reduction strategies have benefits in COPD patients. The long-term efficacy and safety of electronic cigarettes for smoking cessation need to be evaluated in high-risk populations; therefore, it is not possible to recommend their use for smoking cessation in COPD. Future studies with the new generation of nicotine vaccines are necessary to determine their effectiveness in smokers in general and in COPD patients.


Subject(s)
Electronic Nicotine Delivery Systems , Pulmonary Disease, Chronic Obstructive , Smoking Cessation , Humans , Nicotinic Agonists/adverse effects , Tobacco Use Cessation Devices/adverse effects , Bupropion/therapeutic use , Varenicline/adverse effects , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/therapy , Vaccination
17.
AIDS Care ; 35(11): 1741-1748, 2023 11.
Article in English | MEDLINE | ID: mdl-36912767

ABSTRACT

Evidence suggests adverse health effects from vaporized nicotine (VN) use, such as electronic "e" cigarettes, and limited efficacy to aid tobacco cessation. People with HIV (PWH) smoke tobacco at higher rates than the general population, with greater morbidity, highlighting the necessity of effective tobacco cessation tools. PWH may be more vulnerable to adverse effects of VN. Using semi-structured 1:1 interviews, we examined health beliefs regarding VN, patterns of use, and perceived effectiveness for tobacco cessation among PWH in HIV care at three geographically diverse U.S. sites. PWH (n = 24) had limited understanding of VN product content or health effects, presuming VN less harmful than tobacco cigarettes (TC). VN failed to adequately replicate the psychoactive effects or desired ritual of smoking TC. Concurrent TC use, and continuous VN use throughout the day, was common. Satiety using VN was elusive, and consumption quantity was difficult to track. VN had limited desirability and durability as a TC cessation tool among the interviewed PWH.


Subject(s)
HIV Infections , Smoking Cessation , Humans , Nicotine , Tobacco Use Cessation Devices/adverse effects , HIV Infections/drug therapy , HIV Infections/etiology , Health Status , Smoking/adverse effects , Smoking/epidemiology
18.
JAMA Intern Med ; 183(4): 331-339, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36848129

ABSTRACT

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.


Subject(s)
Smoking Cessation , Adult , Humans , Female , Male , Smoking Cessation/psychology , Nicotiana , Aftercare , Bayes Theorem , Tobacco Use Cessation Devices/adverse effects , Patient Discharge
19.
Int J Dent Hyg ; 21(1): 3-17, 2023 Feb.
Article in English | MEDLINE | ID: mdl-35485245

ABSTRACT

BACKGROUND: Nicotine replacement therapy is the first choice pharmacotherapy for smoking cessation. Oral side effects caused due to NRT lead to discontinuation of treatment. The objective of this meta-analysis was to look for the certainty of evidence on the number of patients that reported oral side effects due to the use of NRT. METHOD: Eligible studies were selected and data extraction was carried out independently into a pre-tested data extraction form. Risk of bias was assessed using Cochrane Tool. The heterogeneity between the studies was assessed using Chi-square and I2 tests. Mean difference and Odds ratio at 95% confidence interval were the effect estimates. GRADE working group approach was used to assess the quality of evidence. RESULTS: Twenty-eight studies were included with moderate to low risk of bias. The pooled estimates revealed a statistically significant number of patients developed mouth or throat irritation (2.54 [1.23, 5.25]), or oral soreness (2.22 [1.40, 3.55]) or gastric reflux or vomiting (1.97 [1.34, 2.90]) due to NRT. CONCLUSION: It is important to understand that significant implications are caused due to NRT, on oral health. All patients on NRT must adhere to their regular dentist visits and must check their oral mucosa before initiating NRT.


Subject(s)
Smoking Cessation , Humans , Nicotine/adverse effects , Nicotinic Agonists/therapeutic use , Tobacco Use Cessation Devices/adverse effects , Randomized Controlled Trials as Topic
20.
Addict Behav ; 139: 107579, 2023 04.
Article in English | MEDLINE | ID: mdl-36549102

ABSTRACT

Many adults express interest in e-cigarette cessation; however, there are few empirically tested interventions for quitting vaping. This study seeks to (1) evaluate reasons for quitting e-cigarettes in treatment-seeking adults, and (2) assess the feasibility and acceptability of nicotine replacement therapy (NRT) for e-cigarette cessation. Adult daily e-cigarette users completed qualitative interviews about quitting e-cigarettes, then were randomized to either 28-day supply of combination NRT (21 mg patches, 4 mg lozenges) + supportive booklet or Quitline referral. Primary aims were feasibility (number who enrolled) and acceptability (NRT use, adverse side effects). Exploratory aims evaluated abstinence (7-day point-prevalence) at end of treatment. Of the 30 participants who were enrolled, 50 % (n = 15) were dual users, and 50 % (n = 15) were mono-vapers, 26.6 % (n = 8) of whom were former smokers. Participants reported seeking treatment due to health concerns, dependence, stigma, and cost. Anticipated challenges of quitting vaping were withdrawal, negative mood, sensorimotor habits, and convenience. Most completed the end of treatment survey (n = 24; 80 %). Participants who received NRT reported using the patch M = 10.89 days and lozenges M = 6.39 days, with few days of adverse effects (M = 2.67). At end of treatment, 6/18 (33.3 %; 6 mono and 0 dual users) in the intervention group reported abstinence from vaping, compared to 0 in the control group (Fisher = 5.00, p =.057). In conclusion, adults are interested in quitting e-cigarettes due to negative consequences of use and are willing to use pharmacotherapy. Future research should confirm these results in a larger trial, address cigarette smoking in dual users, and aim to disseminate treatments.


Subject(s)
Alcoholism , Drug-Related Side Effects and Adverse Reactions , Electronic Nicotine Delivery Systems , Smoking Cessation , Vaping , Adult , Humans , Smoking Cessation/methods , Vaping/adverse effects , Tobacco Use Cessation Devices/adverse effects , Alcoholism/etiology , Tablets
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