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Saul Shiffman - One of the best experts on this subject based on the ideXlab platform.

  • randomized trial to compare smoking cessation rates of snus with and without smokeless tobacco health related information and a Nicotine Lozenge
    2019
    Co-Authors: Paul R Nelson, Janine L. Pillitteri, Peter Chen, Deena R Battista, Saul Shiffman
    Abstract:

    Introduction Nicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a Nicotine Lozenge (without relative risk information). Methods A randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days). Results Abstinence rates did not differ significantly between snus and the Nicotine Lozenge-continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the Lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups. Conclusions Smoking cessation rates were comparable between snus and a Nicotine Lozenge, but success rates in this trial were low. Implications This randomized trial of the Nicotine Lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.

  • Nicotine Lozenge efficacy in light smokers
    2005
    Co-Authors: Saul Shiffman
    Abstract:

    Abstract Background : Nicotine replacement therapy (NRT) has been proven to be effective in heterogeneous groups of smokers. However, analyses have not specifically examined efficacy among light smokers (≤15 cigarettes per day). The objective of this study is to assess the efficacy of a Nicotine Lozenge in light smokers. Methods : We conducted a secondary analysis of a randomized, placebo-controlled clinical trial contrasting active 2 mg Nicotine Lozenge with placebo, and contrasting light smokers (≤15 cigarettes per day) with moderate–heavy smokers (>15 cigarettes per day). Participants were 917 smokers who smoked their first cigarette >30 min after waking, and were randomized to active ( n  = 459) or placebo ( n  = 458) Lozenge. Biochemically verified continuous abstinence was measured at 6 weeks and 1 year. Results : Nicotine Lozenge significantly increased quit rates relative to placebo at 6 weeks (45.7% versus 31.1%; OR = 1.9 [1.3–2.8]) and at 1 year (19.2% versus 10.0%; OR = 2.3 [1.3–4.0]) among light smokers. Efficacy among light smokers did not differ from that among heavier smokers (ps > 0.50). Conclusion : The Nicotine Lozenge is effective for light smokers.

  • The effectiveness of Nicotine patch and Nicotine Lozenge in very heavy smokers.
    2005
    Co-Authors: Saul Shiffman, Michael E. Di Marino, Janine L. Pillitteri
    Abstract:

    Abstract The efficacy of Nicotine replacement therapy (NRT) among very heavy and highly dependent smokers was examined in a secondary analysis of two randomized clinical trials of NRT. In the first trial, smokers were assigned to active patch ( n = 249) or placebo ( n = 253) plus intensive behavioral treatment. In the second trial, smokers were assigned to active 4-mg Nicotine Lozenge ( n = 450) or placebo ( n = 451) plus brief behavioral treatment. Nicotine patch and Lozenge significantly increased 6-month continuous abstinence quit rates in both very heavy (≥40 cigarettes per day) and highly dependent (Fagerstrom Tolerance Questionnaire or Fagerstrom Test for Nicotine Dependence score > 7) smokers. The effect of active NRT treatment did not differ significantly by smoking rate or Nicotine dependence, with the exception that the Nicotine patch was significantly more effective than placebo in highly dependent smokers. The Nicotine patch and Lozenge are effective (vs. placebo) even in heavy and highly dependent smokers.

  • Nicotine patch and Lozenge are effective for women
    2005
    Co-Authors: Saul Shiffman, Christine T Sweeney, Carolyn M Dresler
    Abstract:

    : It has been hypothesized that women may be less likely to obtain therapeutic benefit from Nicotine replacement therapy (NRT). The present study tested this hypothesis, using two different types of NRT medications. A secondary analysis of two randomized clinical trials was performed: One compared active 21-mg Nicotine patch with placebo among 193 men and 309 women, and the other compared active 2-mg or 4-mg Nicotine Lozenge with placebo among 788 men and 1,030 women. Using logistic regression analysis of 6-month continuous abstinence and survival analysis, we assessed the efficacy of patch and Lozenge among women and tested for a gender x treatment interaction. Active NRT was more effective than placebo among women, for both patch and Lozenge. In the Lozenge trial, women were less successful than men. The gender x treatment interaction was not significant in either study, whether assessed by logistic regression or survival analysis. In the Lozenge trial, gender moderated the effects of smoking rate and dependence (but not treatment) on outcome: These variables affected success rates only among women. Treatment with Nicotine patch or Lozenge is effective for women, and the analysis did not reveal significant gender differences in efficacy. Gender differences in outcome may be moderated by Nicotine dependence.

  • short communication Nicotine Lozenge efficacy in light smokers
    2005
    Co-Authors: Saul Shiffman
    Abstract:

    Background : Nicotine replacement therapy (NRT) has been proven to be effective in heterogeneous groups of smokers. However, analyses have not specifically examined efficacy among light smokers ( ≤15 cigarettes per day). The objective of this study is to assess the efficacy of a Nicotine Lozenge in light smokers. Methods : We conducted a secondary analysis of a randomized, placebo-controlled clinical trial contrasting active 2 mg Nicotine Lozenge with placebo, and contrasting light smokers (≤15 cigarettes per day) with moderate–heavy smokers (>15 cigarettes per day). Participants were 917 smokers who smoked their first cigarette >30 min after waking, and were randomized to active ( n = 459) or placebo (n = 458) Lozenge. Biochemically verified continuous abstinence was measured at 6 weeks and 1 year. Results : Nicotine Lozenge significantly increased quit rates relative to placebo at 6 weeks (45.7% versus 31.1%; OR = 1.9 [1.3–2.8]) and at 1 year (19.2% versus 10.0%; OR = 2.3 [1.3–4.0]) among light smokers. Efficacy among light smokers did not differ from that among heavier smokers (ps > 0.50). Conclusion : The Nicotine Lozenge is effective for light smokers. © 2004 Elsevier Ireland Ltd. All rights reserved.

Darrell R Schroeder - One of the best experts on this subject based on the ideXlab platform.

  • Nicotine metabolite ratio is associated with Lozenge use but not quitting in smokeless tobacco users
    2016
    Co-Authors: Jon O Ebbert, Herbert H Severson, Brian G Danaher, Neal L Benowitz, Darrell R Schroeder
    Abstract:

    Author(s): Ebbert, Jon O; Severson, Herbert H; Danaher, Brian G; Benowitz, Neal L; Schroeder, Darrell R | Abstract: IntroductionThe Nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of Nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal Nicotine replacement. We evaluated whether the NMR can be used to predict self-reported Nicotine Lozenge use and tobacco abstinence among smokeless tobacco users treated for tobacco dependence.MethodsThis was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg Nicotine Lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and Lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression.ResultsOf the 160 saliva collection kits mailed, 152 were returned. The NMR was not significantly correlated with the baseline amount of smokeless tobacco used, the number of years of tobacco use, or the level of tobacco dependence as measured by the Severson Smokeless Tobacco Dependency Scale. The NMR was positively correlated with Lozenge use (r = 0.21, P = .015), but it did not predict self-reported 7-day point prevalence abstinence at 3 months.ConclusionsFast metabolizers may need to self-administer more Nicotine replacement in the form of Nicotine Lozenges to achieve the same clinical response achieved by slower metabolizers using fewer Lozenges.

  • comparative effectiveness of the Nicotine Lozenge and tobacco free snuff for smokeless tobacco reduction
    2013
    Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R Schroeder
    Abstract:

    Abstract Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the effectiveness of Nicotine Lozenges and tobacco-free snuff for reducing ST use among ST users not ready to quit, but no comparative effectiveness trials of these two products have been conducted. We conducted a multicenter, randomized clinical pilot study evaluating the comparative effectiveness of the 4-mg Nicotine Lozenge and tobacco-free snuff for reducing ST use and increasing tobacco abstinence among ST users with no intention of quitting in the next 30 days. Participants received 8 weeks of treatment and behavioral counseling on tobacco reduction strategies with follow-up to 26 weeks. We randomized 81 participants (40 Nicotine Lozenges, 41 tobacco-free snuff). No significant differences in reduction were observed between the two groups at weeks 8, 12, and 26. No significant differences were observed between groups in Nicotine withdrawal or tobacco craving. However, both groups significantly reduced ( p p  = .615). The 4-mg Nicotine Lozenge and the tobacco-free snuff both appear to be effective and comparable for reducing ST use among ST users not ready to quit in the next 30 days.

  • a randomized clinical trial of Nicotine Lozenge for smokeless tobacco use
    2009
    Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R Schroeder
    Abstract:

    Introduction: Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg Nicotine Lozenge decreases tobacco craving and Nicotine withdrawal symptoms among ST users. Methods: We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the effi cacy of 12 weeks of 4-mg Nicotine Lozenge for ST use. Results: We randomized 270 participants (136 active Lozenge, 134 placebo). No signifi cant differences were observed between the groups in biochemically confi rmed all tobacco abstinence rates at Week 12 (36% Lozenge vs. 27.6% placebo; odds ratio [ OR ] 1.5, 95% CI 0.7 – 2.1; p = .138). However, the 4-mg Nicotine Lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2 – 3.2; p = .011) and selfreported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2 – 3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), Nicotine withdrawal symptoms decreased signifi cantly with time (time effect = − .022 per day, SE = .003; p < .001) and was signifi cantly lower for the active Lozenge (treatment effect = − .213, SE = .071; p = .003). Tobacco craving also decreased signifi cantly following TQD (time effect = − .071, SE = .006; p < .001) and was lower for the active Nicotine Lozenge (treatment effect = − .452, SE = .164; p = .006). Discussion: The 4-mg Nicotine Lozenge increased self-reported but not biochemically confi rmed tobacco abstinence rates at 3 months. The use of the 4-mg Nicotine Lozenge is associated with decreased Nicotine withdrawal symptoms and tobacco craving.

Jon O Ebbert - One of the best experts on this subject based on the ideXlab platform.

  • Nicotine metabolite ratio is associated with Lozenge use but not quitting in smokeless tobacco users
    2016
    Co-Authors: Jon O Ebbert, Herbert H Severson, Brian G Danaher, Neal L Benowitz, Darrell R Schroeder
    Abstract:

    Author(s): Ebbert, Jon O; Severson, Herbert H; Danaher, Brian G; Benowitz, Neal L; Schroeder, Darrell R | Abstract: IntroductionThe Nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of Nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal Nicotine replacement. We evaluated whether the NMR can be used to predict self-reported Nicotine Lozenge use and tobacco abstinence among smokeless tobacco users treated for tobacco dependence.MethodsThis was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg Nicotine Lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and Lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression.ResultsOf the 160 saliva collection kits mailed, 152 were returned. The NMR was not significantly correlated with the baseline amount of smokeless tobacco used, the number of years of tobacco use, or the level of tobacco dependence as measured by the Severson Smokeless Tobacco Dependency Scale. The NMR was positively correlated with Lozenge use (r = 0.21, P = .015), but it did not predict self-reported 7-day point prevalence abstinence at 3 months.ConclusionsFast metabolizers may need to self-administer more Nicotine replacement in the form of Nicotine Lozenges to achieve the same clinical response achieved by slower metabolizers using fewer Lozenges.

  • comparative effectiveness of the Nicotine Lozenge and tobacco free snuff for smokeless tobacco reduction
    2013
    Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R Schroeder
    Abstract:

    Abstract Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the effectiveness of Nicotine Lozenges and tobacco-free snuff for reducing ST use among ST users not ready to quit, but no comparative effectiveness trials of these two products have been conducted. We conducted a multicenter, randomized clinical pilot study evaluating the comparative effectiveness of the 4-mg Nicotine Lozenge and tobacco-free snuff for reducing ST use and increasing tobacco abstinence among ST users with no intention of quitting in the next 30 days. Participants received 8 weeks of treatment and behavioral counseling on tobacco reduction strategies with follow-up to 26 weeks. We randomized 81 participants (40 Nicotine Lozenges, 41 tobacco-free snuff). No significant differences in reduction were observed between the two groups at weeks 8, 12, and 26. No significant differences were observed between groups in Nicotine withdrawal or tobacco craving. However, both groups significantly reduced ( p p  = .615). The 4-mg Nicotine Lozenge and the tobacco-free snuff both appear to be effective and comparable for reducing ST use among ST users not ready to quit in the next 30 days.

  • smokeless tobacco reduction with the Nicotine Lozenge and behavioral intervention
    2010
    Co-Authors: Jon O Ebbert, Amanda Edmonds, Xianghua Luo, Joni Jensen, Dorothy K Hatsukami
    Abstract:

    Introduction: Studies have evaluated smoking reduction with Nicotine replacement therapy to reduce tobacco exposure and facilitate abstinence among cigarette smokers, but none have evaluated a reduction approach in smokeless tobacco (ST) users. Methods: We conducted an open-label pilot study to determine if the 4-mg Nicotine Lozenge with a behavioral intervention could facilitate ST use reduction among ST users compared with a behavioral intervention alone. Eligible subjects were ST users not interested in quitting. Results: One hundred and two subjects were randomized. Both interventions were associated with significant decreases in ST use and toxicant exposure and with increased abstinence, quit attempts, and duration of abstinence. However, no significant differences were observed between groups for these outcomes. Discussion: A behavioral intervention with or without the Nicotine Lozenge may be effective for decreasing both ST use and toxicant exposure and for increasing tobacco abstinence, quit attempts, and duration of abstinence. The use of reduction strategies for ST users not interested in quitting deserves further evaluation as an intervention strategy.

  • a randomized clinical trial of Nicotine Lozenge for smokeless tobacco use
    2009
    Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R Schroeder
    Abstract:

    Introduction: Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg Nicotine Lozenge decreases tobacco craving and Nicotine withdrawal symptoms among ST users. Methods: We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the effi cacy of 12 weeks of 4-mg Nicotine Lozenge for ST use. Results: We randomized 270 participants (136 active Lozenge, 134 placebo). No signifi cant differences were observed between the groups in biochemically confi rmed all tobacco abstinence rates at Week 12 (36% Lozenge vs. 27.6% placebo; odds ratio [ OR ] 1.5, 95% CI 0.7 – 2.1; p = .138). However, the 4-mg Nicotine Lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2 – 3.2; p = .011) and selfreported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2 – 3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), Nicotine withdrawal symptoms decreased signifi cantly with time (time effect = − .022 per day, SE = .003; p < .001) and was signifi cantly lower for the active Lozenge (treatment effect = − .213, SE = .071; p = .003). Tobacco craving also decreased signifi cantly following TQD (time effect = − .071, SE = .006; p < .001) and was lower for the active Nicotine Lozenge (treatment effect = − .452, SE = .164; p = .006). Discussion: The 4-mg Nicotine Lozenge increased self-reported but not biochemically confi rmed tobacco abstinence rates at 3 months. The use of the 4-mg Nicotine Lozenge is associated with decreased Nicotine withdrawal symptoms and tobacco craving.

Dorothy K Hatsukami - One of the best experts on this subject based on the ideXlab platform.

  • timing of Nicotine Lozenge administration to minimize trigger induced craving and withdrawal symptoms
    2017
    Co-Authors: Michael Kotlyar, Bruce R Lindgren, John P Vuchetich, Anne M Mills, Elizabeth Amiot, Dorothy K Hatsukami
    Abstract:

    Abstract Introduction Smokers are often advised to use Nicotine Lozenge when craving or withdrawal symptoms occur. This may be too late to prevent lapses. This study assessed if Nicotine Lozenge use prior to a common smoking trigger can minimize trigger induced increases in craving and withdrawal symptoms. Methods Eighty-four smokers completed two laboratory sessions in random order. At one session, Nicotine Lozenge was given immediately after a stressor (to approximate current recommended use – i.e., after craving and withdrawal symptoms occur); at the other session subjects were randomized to receive Nicotine Lozenge at time points ranging from immediately to 30 min prior to the stressor. Withdrawal symptoms and urge to smoke were measured using the Minnesota Nicotine Withdrawal Scale and the Questionnaire of Smoking Urges (QSU). Results Relative to receiving Lozenge after the stressor, a smaller increase in pre-stressor to post-stressor withdrawal symptom scores occurred when Lozenge was used immediately (p = 0.03) and 10 min prior (p = 0.044) to the stressor. Results were similar for factors 1 and 2 of the QSU when Lozenge was used immediately prior to the stressor (p  Conclusions Administering the Nicotine Lozenge prior to a smoking trigger can decrease trigger induced craving and withdrawal symptoms. Future studies are needed to determine if such use would increase cessation rates. Clinicaltrials.gov # NCT01522963

  • smokeless tobacco reduction with the Nicotine Lozenge and behavioral intervention
    2010
    Co-Authors: Jon O Ebbert, Amanda Edmonds, Xianghua Luo, Joni Jensen, Dorothy K Hatsukami
    Abstract:

    Introduction: Studies have evaluated smoking reduction with Nicotine replacement therapy to reduce tobacco exposure and facilitate abstinence among cigarette smokers, but none have evaluated a reduction approach in smokeless tobacco (ST) users. Methods: We conducted an open-label pilot study to determine if the 4-mg Nicotine Lozenge with a behavioral intervention could facilitate ST use reduction among ST users compared with a behavioral intervention alone. Eligible subjects were ST users not interested in quitting. Results: One hundred and two subjects were randomized. Both interventions were associated with significant decreases in ST use and toxicant exposure and with increased abstinence, quit attempts, and duration of abstinence. However, no significant differences were observed between groups for these outcomes. Discussion: A behavioral intervention with or without the Nicotine Lozenge may be effective for decreasing both ST use and toxicant exposure and for increasing tobacco abstinence, quit attempts, and duration of abstinence. The use of reduction strategies for ST users not interested in quitting deserves further evaluation as an intervention strategy.

  • reduced Nicotine content cigarettes effects on toxicant exposure dependence and cessation
    2010
    Co-Authors: Dorothy K Hatsukami, Michael Kotlyar, Joni Jensen, Louise Hertsgaard, Yan Zhang, Steven G Carmella, Sharon S Allen, Peter G Shields, Sharon E Murphy, Irina Stepanov
    Abstract:

    Aims To examine the effects of reduced Nicotine cigarettes on smoking behavior, toxicant exposure, dependence andabstinence.Design Randomized,parallelarm,semi-blindedstudy.Setting Universityof MinnesotaTobaccoUse Research Center.Interventions Six weeks of: (i) 0.05 mg Nicotine yield cigarettes; (ii) 0.3 mg Nicotine yield cigarettes; or (iii) 4 mg Nicotine Lozenge; 6 weeks of follow-up. Measurements Compensatory smoking behavior, biomarkers of exposure, tobacco dependence, tobacco withdrawal and abstinence rate. Findings Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and Nicotine Lozenge were associated with reduced carcinogen exposure, Nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the Nicotine Lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as Nicotine Lozenge. Conclusion The 0.05 mg Nicotine yield cigarettes may be a tobacco product that can facilitate cessation; however, future research is clearly needed to support these preliminary findings.

  • Nicotine pharmacokinetics and subjective effects of three potential reduced exposure products moist snuff and Nicotine Lozenge
    2007
    Co-Authors: Michael Kotlyar, Irene M Mendozabaumgart, Paul R Pentel, Brianne C Barnett, Rachel Feuer, Erin A Smith, Dorothy K Hatsukami
    Abstract:

    Objective: To compare Nicotine pharmacokinetics and subjective effects of three new smokeless tobacco potential reduced exposure products (PREPs; Ariva, Revel and Stonewall) with moist snuff (Copenhagen) and medicinal Nicotine (Commit Lozenge). Methods: 10 subjects completed a randomised, within-subject, crossover study. Subjects used one product for 30 min at each of the five laboratory sessions. Maximal Nicotine concentration (C max ) was determined and area under the concentration time curve (AUC) was calculated for a 90-min period (during use and 60 min after use). Nicotine craving, withdrawal symptoms and ratings of product effects and liking were measured during product use. Results: Nicotine AUC and C max were higher for Copenhagen than for any other product (p max for Commit was also higher than for Stonewall (p = 0.03). Craving was lowest during use of Copenhagen (p Conclusion: The new smokeless tobacco PREPs result in lower Nicotine concentrations and equivalent or lower reductions in subjective measures compared with medicinal Nicotine. Since health effects of PREPs are largely unknown, medicinal Nicotine should be preferentially encouraged for smokers or smokeless tobacco users wishing to switch to lower-risk products.

Timothy B Baker - One of the best experts on this subject based on the ideXlab platform.

  • comparative effects of varenicline or combination Nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt
    2020
    Co-Authors: Nayoung Kim, Danielle E Mccarthy, Megan E Piper, Timothy B Baker
    Abstract:

    BACKGROUND AND AIMS The 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. DESIGN Secondary 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. SETTING Research clinics in Madison and Milwaukee, Wisconsin, USA. PARTICIPANTS A total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6). INTERVENTIONS Twelve 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. MEASUREMENTS The 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. FINDINGS Pre-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. CONCLUSION Among 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.

  • anxiety sensitivity and distress tolerance in smokers relations with tobacco dependence withdrawal and quitting success
    2020
    Co-Authors: Tanya R Schlam, Timothy B Baker, Stevens S Smith, Jessica W Cook, Megan E Piper
    Abstract:

    INTRODUCTION This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of Nicotine patch, Nicotine patch plus Nicotine Lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus Lozenge versus patch alone. CONCLUSIONS DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received Nicotine patch plus Nicotine Lozenge rather than Nicotine patch alone. TRIAL REGISTRATION NCT01553084.

  • triple smoking cessation therapy with varenicline Nicotine patch and Nicotine Lozenge a pilot study to assess tolerability satisfaction and end of treatment quit rates
    2018
    Co-Authors: Kristin M Berg, Timothy B Baker, Douglas E. Jorenby, Michael C Fiore
    Abstract:

    Introduction: The majority of attempts to stop smoking end in failure. One way to improve success may be to explore different combinations of existing cessation medications. Aims: This observational study examined ‘triple therapy’ (varenicline + Nicotine patch + Nicotine Lozenge) in 36 smokers trying to quit. Methods: A 12-week, observational study exploring tolerability, via adverse events (AEs) elicited at each of nine phone assessments. Secondary outcomes included satisfaction rates, medication changes and self-reported quit rates at week 12. Results: Thirty five of thirty six participants reported at least one AE. Insomnia (75%), abnormal dreams (72%) and nausea (64%) were most common. Most were mild to moderate. No deaths, hospitalisations, cardiovascular events or suicidality were reported. Six participants (17%) decreased the dose of at least one medication, 5 (14%) decreased the dose then discontinued at least one medication and 13 (36%) discontinued at least one medication without trying a lesser dose. Participants were highly satisfied with their medications, and 58% reported quitting at 12 weeks, with 38% reporting prolonged abstinence. Conclusions: Despite high rates of AEs and medication changes, high rates of satisfaction and self-reported quitting, with no serious AEs, were observed with triple therapy. Additional data on tolerability and efficacy are needed. Trial Registration: Clinicaltrials.gov number NCT02681510.

  • effects of Nicotine patch vs varenicline vs combination Nicotine replacement therapy on smoking cessation at 26 weeks a randomized clinical trial
    2016
    Co-Authors: Timothy B Baker, James H Stein, Daniel M Bolt, David Fraser, Megan E Piper, Stevens S Smith, Michael C Fiore
    Abstract:

    Importance 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. Objective To compare the efficacies of varenicline, combination Nicotine replacement therapy (C-NRT), and the Nicotine patch for 26-week quit rates. Design, Setting, and Participants 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. Interventions 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. Main Outcomes and Measures 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. Results 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. Conclusions and Relevance 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. Trial Registration clinicaltrials.gov Identifier:NCT01553084

  • anxiety diagnoses in smokers seeking cessation treatment relations with tobacco dependence withdrawal outcome and response to treatment
    2011
    Co-Authors: Megan E Piper, Douglas E. Jorenby, Jessica W Cook, Tanya R Schlam, Timothy B Baker
    Abstract:

    Aims  To understand the relations among anxiety disorders and tobacco dependence, withdrawal symptoms, response to smoking cessation pharmacotherapy and ability to quit smoking. Design  Randomized placebo-controlled clinical trial. Participants received six 10-minute individual counseling sessions and either: placebo, bupropion SR, Nicotine patch, Nicotine Lozenge, bupropion SR + Nicotine Lozenge or Nicotine patch + Nicotine Lozenge. Setting  Two urban research sites. Participants  Data were collected from 1504 daily smokers (>9 cigarettes per day) who were motivated to quit smoking and did not report current diagnoses of schizophrenia or psychosis or bupropion use. Measurements  Participants completed baseline assessments, the Composite International Diagnostic Interview and ecological momentary assessments for 2 weeks. Findings  A structured clinical interview identified participants who ever met criteria for a panic attack (n = 455), social anxiety (n = 199) or generalized anxiety disorder (n = 99), and those who qualified for no anxiety diagnosis (n = 891). Smokers with anxiety disorders reported higher levels of Nicotine dependence and pre-quit withdrawal symptoms. Those ever meeting criteria for panic attacks or social anxiety disorder showed greater quit-day negative affect. Smokers ever meeting criteria for anxiety disorders were less likely to be abstinent at 8 weeks and 6 months post-quit and showed no benefit from single-agent or combination-agent pharmacotherapies. Conclusions  Anxiety diagnoses were common among treatment-seeking smokers and were related to increased motivation to smoke, elevated withdrawal, lack of response to pharmacotherapy and impaired ability to quit smoking. These findings could guide treatment assignment algorithms and treatment development for smokers with anxiety diagnoses.