Long-term nicotine replacement therapy: a randomized clinical trial.
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ABSTRACT:
SUBMITTER: Schnoll RA
PROVIDER: S-EPMC4410859 | biostudies-literature | 2015 Apr
REPOSITORIES: biostudies-literature
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Long-term nicotine replacement therapy: a randomized clinical trial.
Schnoll Robert A RA Goelz Patricia M PM Veluz-Wilkins Anna A Blazekovic Sonja S Powers Lindsay L Leone Frank T FT Gariti Peter P Wileyto E Paul EP Hitsman Brian B
JAMA internal medicine 20150401 4
<h4>Importance</h4>The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks. This decision was based in part on data showing increased efficacy for 24 weeks of treatment. Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit.<h4>Objective</h4>To compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.<h4>Des ...[more]
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Project description:Importance:Smokers with chronic obstructive pulmonary disease (COPD) have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might offer a strategy for reducing harm from cigarettes and provide a pathway for later cessation. Objective:To compare the effect of LT-NRT vs standard smoking cessation (SSC) on exposure to cigarette smoke, harm related to smoking, and cessation among smokers with COPD. Design, Setting, and Participants:This unblinded, randomized clinical trial recruited smokers who self-reported a diagnosis of COPD at any level of readiness to quit from May 23, 2014, through November 30, 2015. The 12-month follow-up was completed December 6, 2016. Patients were recruited at a clinical research unit of an academic medical center. Analysis was based on intention to treat and performed from March 8 through November 30, 2017. Interventions:Standard smoking cessation treatment included 10 weeks of NRT and 4 follow-up counseling sessions for those willing to make a quit attempt. Long-term NRT included 12 months of NRT and 6 follow-up counseling sessions regardless of initial willingness to quit. Overall, 198 patients were randomized to SSC, and 197 were included in the primary analysis; 200 patients were randomized to LT-NRT, and 197 were included in the primary analysis. Main Outcomes and Measures:The primary outcome was 7-day abstinence verified by carbon monoxide (CO) levels at 12 months. Secondary outcomes included cigarettes smoked per day (CPD), exposure to CO, urinary excretion of 4-methylnitrosamino-1-3-pyridyl-1-butanol (NNAL) (a smoking-related carcinogen), and adverse events. Results:Among 398 patients who were randomized (59.8% female; mean [SD] age, 56.0 [9.3] years), the mean (SD) CPD was 23.1 (12.3). Twelve-month follow-up was completed by 373 participants (93.7%), and 394 (99.0%) were included in the primary analysis. At 12 months, CO-verified abstinence occurred in 23 of 197 participants (11.7%) in the SSC arm and 24 of 197 (12.2%) in the LT-NRT arm (risk difference, 0.5%; 95% CI, -5.9% to 6.9%). Continuing smokers in the SSC and LT-NRT arms had similar, significantly reduced harms caused by smoking, including cigarette consumption by 12.4 and 14.5 CPD, respectively, exhaled CO level by 5.5 and 7.8 ppm, respectively, and mean urinary NNAL excretion by 21.7% and 23.0%, respectively. In multivariate analyses, continuing smokers with greater adherence to NRT experienced less reduction in NNAL exposure. The frequency of major adverse cardiac events was similar in both groups. Conclusions and Relevance:Similar rates of cessation and similar reductions in exposure to tobacco smoke resulted with LT-NRT and SSC. Among continuing smokers, ongoing use of NRT was not associated with reductions in smoke exposure. Trial Registration:ClinicalTrials.gov Identifier: NCT02148445.
| S-EPMC6324503 | biostudies-literature
Project description:BackgroundOur group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT.Methods/designTrained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline.DiscussionIf the study finds that the mailed distribution of free NRT is effective at promoting long-term cessation, it would provide further evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it.Trial registrationClinicalTrials.gov : NCT01429129 , Registered 2 September 2011; NCT03097445 , Registered 25 March 2017.
| S-EPMC5516338 | biostudies-literature
Project description:BackgroundPrimary care is the most important point of healthcare contact for smokers. Brief physician advice to quit, based on the 5As/AAR model, offers some efficacy but is inconsistently administered and has limited population impact. Nicotine replacement therapy (NRT) sampling, defined as provision of a brief NRT starter kit, when added to the 5As/AAR, is well-suited to primary care because it is simple, brief, and can be provided to all smokers. This article describes the design and methods of an ongoing comparative effectiveness trial testing standard care vs. standard care + NRT sampling within primary care.MethodsSmokers were recruited directly from primary care practices between July 2014 and December 2017 within an established network of South Carolina clinics. Interventions were delivered randomly by clinic personnel, and phone-based follow-ups were centrally coordinated by research staff to track outcomes through six months post-intervention. Primary study aims are to examine the impact of NRT sampling on smoking, inclusive of cessation, quit attempts, and uptake of evidence-based treatment.ResultsTwenty-two clinics were recruited. Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63. Average patient age across clinics was 52.9 years and smoking prevalence across ranged from 10.6% to 28.5%.ConclusionImproving the effectiveness and reach of brief interventions within primary care could have a considerable impact on population quit rates. We consider the advantages and disadvantages of key methodological decisions relevant to the design of future primary care-based cessation trials.
| S-EPMC6133738 | biostudies-literature
Project description:Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality.To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates.Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization.Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n?=?241); (2) varenicline only (including 1 prequit week; n?=?424); and (3) C-NRT (nicotine patch?+?nicotine lozenge; n?=?421). Six counseling sessions were offered.The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52.Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion.Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.clinicaltrials.gov Identifier: NCT01553084.
| S-EPMC4824537 | biostudies-literature
Project description:Background and aimsWithin the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits.DesignCluster-randomized clinical trial.SettingTwenty-two primary care clinics in South Carolina, USA.ParticipantsAdult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics).MeasurementsThe primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline.FindingsSeven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7).ConclusionProviding smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.
| S-EPMC7292788 | biostudies-literature
Project description:Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.
| S-EPMC3198706 | biostudies-literature
Project description:Given the rapid increase in the popularity of e-cigarettes and the paucity of associated longitudinal health-related data, the need to assess the potential risks of long-term use is essential.To compare exposure to nicotine, tobacco-related carcinogens, and toxins among smokers of combustible cigarettes only, former smokers with long-term e-cigarette use only, former smokers with long-term nicotine replacement therapy (NRT) use only, long-term dual users of both combustible cigarettes and e-cigarettes, and long-term users of both combustible cigarettes and NRT.Cross-sectional study.United Kingdom.The following 5 groups were purposively recruited: combustible cigarette-only users, former smokers with long-term (?6 months) e-cigarette-only or NRT-only use, and long-term dual combustible cigarette-e-cigarette or combustible cigarette-NRT users (n = 36 to 37 per group; total n = 181).Sociodemographic and smoking characteristics were assessed. Participants provided urine and saliva samples and were analyzed for biomarkers of nicotine, tobacco-specific N-nitrosamines (TSNAs), and volatile organic compounds (VOCs).After confounders were controlled for, no clear between-group differences in salivary or urinary biomarkers of nicotine intake were found. The e-cigarette-only and NRT-only users had significantly lower metabolite levels for TSNAs (including the carcinogenic metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL]) and VOCs (including metabolites of the toxins acrolein; acrylamide; acrylonitrile; 1,3-butadiene; and ethylene oxide) than combustible cigarette-only, dual combustible cigarette-e-cigarette, or dual combustible cigarette-NRT users. The e-cigarette-only users had significantly lower NNAL levels than all other groups. Combustible cigarette-only, dual combustible cigarette-NRT, and dual combustible cigarette-e-cigarette users had largely similar levels of TSNA and VOC metabolites.Cross-sectional design with self-selected sample.Former smokers with long-term e-cigarette-only or NRT-only use may obtain roughly similar levels of nicotine compared with smokers of combustible cigarettes only, but results varied. Long-term NRT-only and e-cigarette-only use, but not dual use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.Cancer Research UK.
| S-EPMC5362067 | biostudies-literature
Project description:We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.
| S-EPMC3679235 | biostudies-literature
Project description:ImportanceThe complications of corticosteroids make the inclusion of these drugs in immunosuppressive protocols for kidney transplant patients undesirable. However, cessation of corticosteroids is associated with a higher risk of short-term rejection, and the long-term outcomes of patients withdrawn from corticosteroids remain uncertain.ObjectiveTo compare long-term kidney transplant outcomes of patients randomized to continue or withdraw corticosteroids.Design, setting, and participantsThis prospective multicenter randomized double-blind placebo-controlled trial was conducted between November 1999 and December 2002 with linkage to a mandatory national registry with validated outcome ascertainment until June 8, 2018. The study included 28 kidney transplant centers in the United States, including 386 low- to moderate-immune risk adult recipients of a living or deceased donor kidney transplant without delayed graft function or short-term rejection in the first week after transplant. Analyses were intention to treat. Analysis began September 2018 and ended June 2019.InterventionsPatients were randomized to receive tacrolimus and mycophenolate mofetil with or without corticosteroids 7 days after transplant.Main outcomes and measuresKidney allograft failure from any cause including death and allograft failure censored for patient death defined by the requirement for long-term dialysis or repeat transplant.ResultsOf 385 patients, 191 were assigned to withdraw from corticosteroids (mean [SD] age, 46.5 [12.1] years), and 194 patients were assigned to continued corticosteroids (mean [SD] age, 46.3 [12.6] years). The median (interquartile range) follow-up time was 15.8 (12.0-16.3) years after transplant. The adjusted hazard ratios of allograft failure from any cause including death was 0.83 (95% CI, 0.62-1.10; P = .19) and for allograft failure censored for patient death was 0.78 (95% CI, 0.52-1.19; P = .25) and did not differ between the patients assigned to withdraw from corticosteroids vs assigned to continued corticosteroids. Results were consistent in a per-protocol analysis among 223 patients who continued the trial-assigned treatment of corticosteroid withdrawal (n = 114) or corticosteroids (n = 109) through at least 5 years after transplant. The outcomes of trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs.Conclusions and relevanceLong-term corticosteroids may not be necessary as part of a calcineurin-based multiple drug immunosuppressive regimen in low- to moderate-immune risk kidney transplant recipients.
| S-EPMC7859872 | biostudies-literature
Project description:Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR).A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures.The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups.Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.
| S-EPMC4884360 | biostudies-literature