Nicotine replacement therapy versus control for smoking cessation.
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ABSTRACT:
SUBMITTER: Hartmann-Boyce J
PROVIDER: S-EPMC6353172 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThis study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.MethodsAn open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum.ResultsWomen in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth.ConclusionsThe addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.
| S-EPMC3602964 | biostudies-literature
Project description:ObjectiveRecent evidence suggests that the efficacy of smoking cessation pharmacotherapy can vary across patients based on their genotypes. This study tests whether the coding variant rs16969968 in the CHRNA5 nicotinic receptor gene predicts the effects of combination nicotine replacement therapy (cNRT) and varenicline on treatment outcomes.MethodIn two randomized smoking cessation trials comparing cNRT vs. placebo, and varenicline vs. placebo, we used logistic regression to model associations between CHRNA5 rs16969968 and abstinence at end of treatment.ResultsFor abstinence at end of treatment, there was an interaction between cNRT and rs16969968 (X(2)=8.15, df=2, omnibus-p=0.017 for the interaction); individuals with the high-risk AA genotype were more likely to benefit from cNRT. In contrast, varenicline increased abstinence, but its effect did not vary with CHRNA5. However, the genetic effects differed between the placebo control groups across two trials (wald=3.94, df=1, p=0.047), this non-replication can alter the interpretation of pharmacogenetic findings.ConclusionsResults from two complementary smoking cessation trials demonstrate inconsistent genetic results in the placebo arms. This evidence highlights the need to compare the most effective pharmacotherapies with the same placebo control to establish pharmacogenetic evidence to aid decisions on medication choice for patients trying to quit smoking.
| S-EPMC4537319 | biostudies-literature
Project description: Not available
| S-EPMC10278922 | biostudies-literature
Project description:ObjectiveHeavy drinking is common among smokers and is associated with especially poor health outcomes. Varenicline may affect mechanisms and clinical outcomes that are relevant for both smoking cessation and alcohol use. The current study examines whether varenicline, relative to nicotine replacement therapy, yields better smoking cessation outcomes among binge drinking smokers.MethodSecondary data analyses of a comparative effectiveness randomized controlled trial of three smoking cessation pharmacotherapies (12 weeks of varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions were conducted. Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting. Smoking cessation outcome was 7-day biochemically confirmed point-prevalence abstinence.ResultsBinge drinkers had higher relapse rates than moderate drinkers at 4-week post-target quit day but not at the end of treatment or long-term follow up (12 and 26 weeks). Varenicline did not yield superior smoking cessation outcomes among binge drinkers, nor did it affect alcohol use early in the quit attempt. Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.ConclusionsVarenicline did not yield higher smoking abstinence rates or reduce alcohol use among binge drinkers. Varenicline did reduce alcohol-related cigarette craving but this did not translate to meaningful differences in smoking abstinence. Varenicline's effects on smoking abstinence do not appear to vary significantly as a function of drinking status.
| S-EPMC7437557 | biostudies-literature
Project description:We investigated the association of catechol O-methyltransferase (COMT) genotype with abstinence following a smoking cessation attempt among a large cohort of smokers who attempted to quit using either the nicotine transdermal patch or placebo and were followed up over an 8-year period following their initial cessation attempt. In addition, we examined the possible moderating influence of sex on any association. The genotype x treatment interaction effect at 12-week follow-up indicated a greater benefit of active nicotine replacement treatment compared with placebo on likelihood of abstinence in the COMT Met/Met genotype group (33% versus 12%), in comparison to the Met/Val + Val/Val group (22% versus 16%). Our results indicate that COMT genotype may moderate the effect of active transdermal nicotine patch compared with placebo, with reduced relative benefit of nicotine replacement therapy in individuals with Met/Val or Val/Val genotype. Our data follow an emerging pattern of results suggesting that genetic variation in the dopamine pathway may provide a future basis for tailored smoking cessation therapies, but indicate that different genes influencing various components of this pathway may have different effects on response to smoking cessation pharmacotherapy.
| S-EPMC2031911 | biostudies-literature
Project description: Not available
| S-EPMC10681200 | 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
Project description:IntroductionThe QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service.MethodsQuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking.ResultsRetention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups.ConclusionsClients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm.Trial registration numberACTRN12617000849392.ImplicationsThis pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.
| S-EPMC7885782 | biostudies-literature
Project description:Background and aimsThe phase-based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre-cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C-NRT) relative to nicotine patch monotherapy on pre-cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators.DesignSecondary mediation analysis of data from the open-label, randomized Wisconsin Smokers' Health Study 2, a comparative effectiveness trial of varenicline or C-NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach.SettingResearch clinics in Madison and Milwaukee, Wisconsin, USA.ParticipantsA total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6).InterventionsTwelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling.MeasurementsThe primary abstinence outcome was biochemically verified 7-day point-prevalence abstinence 4 weeks post-target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre-cessation phase) to 4 weeks after (cessation phase) the TQD.FindingsPre-cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34-0.79], smoking expectancies (aOR = 0.46-0.79) and quitting motivation (aOR = 1.35-7.21) significantly predicted 4-week post-TQD abstinence (P < 0.05). Significant varenicline mediation occurred via greater suppression in pre-cessation craving [mediated effect (ab) = 0.09, standard error (SE) = 0.03, 95% confidence interval (CI) = 0.04-0.14] and smoking expectancies (ab = 0.06, SE = 0.02, 95% CI = 0.02-0.12). C-NRT mediation occurred via greater reduction in pre-post-TQD changes in craving (ab = 0.04, SE = 0.02, 95% CI = 0.01-0.08) and expectancies (ab = 0.03, SE = 0.02, 95% CI = 0.001-0.07), relative to patch monotherapy.ConclusionAmong adult smokers seeking to quit, varenicline seems to work through its effects on suppression of craving and smoking expectancies pre-cessation while combination nicotine replacement therapy mediation seems to work through cessation-related reduction in craving and smoking expectancies changes.
| S-EPMC7930141 | biostudies-literature
Project description:BackgroundInternet discussion forums provide new, albeit less used data sources for exploring personal experiences of illness and treatment strategies.ObjectiveTo gain an understanding of how discussion forum participants value nicotine replacement therapy (NRT) in smoking cessation (SC).SettingFinnish national Internet-based discussion forum, STUMPPI, supporting SC and consisting of ten free discussion areas, each with a different focus. The analysis was based on STUMPPI forum participants' postings (n = 24 481) in five discussion areas during January 2007-January 2012.DesignInductive content analysis of the postings concerning NRT use or comparing NRT to other SC methods.ResultsThree major themes related to NRT in SC emerged from the discussions. These were as follows: (I) distrust and negative attitude towards NRT; (II) neutral acceptance of NRT as a useful SC method; and (III) trust on the crucial role of NRT and other SC medicines. The negative attitude was related to following perceptions: NRT use maintains tobacco dependence, fear of NRT dependence or experience of not gaining help from NRT use. NRT was perceived to be useful particularly in the initiation of SC attempts and in dealing with physiological dependence. The most highlighted factors of successful quitting were quitters' own psychological empowerment and peer support from the discussion community.ConclusionsThe majority of STUMPPI forum participants had low or balanced expectations towards the role of NRT in SC. More research from the smokers' and quitters' perspective is needed to assess the real value of NRT compared to other methods in SC.
| S-EPMC5810674 | biostudies-literature