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Dorothy K. Hatsukami - One of the best experts on this subject based on the ideXlab platform.
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Gender differences in snus versus Nicotine Gum for cigarette avoidance among a sample of US smokers.
Drug and alcohol dependence, 2016Co-Authors: Alicia M. Allen, Joni Jensen, Rachel Isaksson Vogel, Ellen Meier, Amanda Anderson, Herbert H. Severson, Dorothy K. HatsukamiAbstract:Abstract Introduction Women are more susceptible to the harmful effects of cigarette smoking. Thus, identifying effective harm reduction approaches for women is necessary. The goal of this project was to examine gender differences in response to snus versus Nicotine Gum for cigarette avoidance, as a means of harm reduction. Methods Participants were randomly assigned to use snus or Nicotine Gum as a method to avoid cigarette smoking. Participants attended clinic visits to receive study product, as well as provide biological samples to assess smoking avoidance and biomarkers and report on use of study product and cigarettes. A secondary analysis comparing men and women by randomization to study product was conducted. Results Participants (n = 391; 47% women) were randomized into the snus group (n = 196; 45% women) and the Gum group (n = 195; 49% women). Men used more snus whereas women used more Gum (p = 0.02). During treatment, men in the snus group had higher total Nicotine equivalent values whereas women did not vary by group (p = 0.03). Overall, fewer men in the snus group completely avoided cigarettes compared to men in the Gum group (e.g., continuous abstinence at Week 12: odds ratio = 0.43, 95% confidence interval = 0.20–0.93). Among women, there were no differences by randomization in cigarette avoidance. Conclusions Despite a number of gender differences in response to snus versus Nicotine Gum, these data suggest that snus may not be an optimal harm reduction approach for either gender.
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Nicotine self administration cigarette versus Nicotine Gum diurnal topography
Human Psychopharmacology-clinical and Experimental, 2006Co-Authors: Marc E Mooney, Charles E. Green, Dorothy K. HatsukamiAbstract:The few extant reports examining the relationship between diurnal patterns of pre-cessation smoking and cessation Nicotine replacement use suggest that this relationship may be important in preventing smoking relapse. The current study evaluated three interventions to increase Nicotine Gum use: standard treatment (ST, N = 31), ST plus brief feedback about Nicotine attitudes and knowledge (BF, N = 32), or BF plus contingent monetary reinforcement for Nicotine Gum use (CM, N = 34). Subsets of the 97 randomized subjects were selected based on availability of adequate data for analyses: baseline phase (i.e., 6–7 days of ad libitum smoking, N = 63) or the treatment phase (i.e., 13–15 days of treatment, N = 47). For both cigarettes and Nicotine Gum, participants showed a characteristic pattern of increasing use during the morning hours, followed by stable use in the afternoon and evening, with a steep decrease prior to sleep onset. Patterns of diurnal Gum use did not differ by compliance intervention. Greater morning use of cigarettes or Gum was associated with smoking relapse while greater evening and night use of cigarettes or Gum was associated with abstinence. Understanding of diurnal patterns of smoking and NRT use may ultimately inform tailored scheduling of NRT. Copyright © 2006 John Wiley & Sons, Ltd.
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Nicotine self‐administration: cigarette versus Nicotine Gum diurnal topography
Human psychopharmacology, 2006Co-Authors: Marc E Mooney, Charles E. Green, Dorothy K. HatsukamiAbstract:The few extant reports examining the relationship between diurnal patterns of pre-cessation smoking and cessation Nicotine replacement use suggest that this relationship may be important in preventing smoking relapse. The current study evaluated three interventions to increase Nicotine Gum use: standard treatment (ST, N = 31), ST plus brief feedback about Nicotine attitudes and knowledge (BF, N = 32), or BF plus contingent monetary reinforcement for Nicotine Gum use (CM, N = 34). Subsets of the 97 randomized subjects were selected based on availability of adequate data for analyses: baseline phase (i.e., 6–7 days of ad libitum smoking, N = 63) or the treatment phase (i.e., 13–15 days of treatment, N = 47). For both cigarettes and Nicotine Gum, participants showed a characteristic pattern of increasing use during the morning hours, followed by stable use in the afternoon and evening, with a steep decrease prior to sleep onset. Patterns of diurnal Gum use did not differ by compliance intervention. Greater morning use of cigarettes or Gum was associated with smoking relapse while greater evening and night use of cigarettes or Gum was associated with abstinence. Understanding of diurnal patterns of smoking and NRT use may ultimately inform tailored scheduling of NRT. Copyright © 2006 John Wiley & Sons, Ltd.
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interventions to increase use of Nicotine Gum a randomized controlled single blind trial
Nicotine & Tobacco Research, 2005Co-Authors: Marc E Mooney, David A Babb, Joni Jensen, Dorothy K. HatsukamiAbstract:Medication noncompliance with smoking cessation pharmacotherapies is a significant problem in both research and clinical settings. This randomized, controlled, single-blind study compared three single-session psychological interventions to increase use of Nicotine Gum during a 15-day treatment period. A total of 97 adult smokers were randomized to receive standard treatment (ST, n=31), brief feedback (BF, n=32) plus ST, or contingency management (CM; i.e., payment for chewing at least 12 pieces/day on 10 of 15 intervention days, n=34) plus ST and BF. Only the CM condition led to significantly greater average daily Gum use (pieces/day: ST, 6.17; BF, 7.81; CM, 10.17 [p values <.05]) and higher rates of compliance (ST, 13.6%; BF, 25.2%; CM, 65.6% [p values <.001]). No differences were observed in smoking abstinence, Nicotine withdrawal, or urinary cotinine as a function of treatment. Implications of the present findings are discussed, including application to clinical trials and extension to real-world use of Nicotine Gum.
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Effects of short-term use of Nicotine Gum in pregnant smokers
Clinical pharmacology and therapeutics, 1996Co-Authors: Cheryl Oncken, Dorothy K. Hatsukami, Harry A. Lando, Virginia R. Lupo, Lynne M. Gibeau, Rebecca J. HansenAbstract:Objectives To compare blood concentrations of Nicotine and cotinine and maternal and fetal hemodynamic effects resulting from use of Nicotine Gum versus cigarette smoking in pregnant smokers. Methods Pregnant women (24 to 36 weeks' gestation) who smoked chronically were randomly assigned with a 1:2 randomization scheme to either a group that smoked cigarettes (n = 10) or to a group that stopped smoking and chewed at least six pieces of Nicotine Gum (2 mg Nicotine per piece) per day (n = 19). Blood Nicotine and cotinine concentrations, maternal heart rate and blood pressure, uterine resistance index, and fetal heart rate and umbilical artery resistance index were obtained before and after one cigarette was smoked at baseline and after 5 continuous days of either chewing Gum or smoking. Results A significant reduction from baseline in Nicotine (p < 0.0001) and cotinine (p < 0.0025) concentrations was observed in those who chewed Nicotine Gum compared with those who smoked cigarettes. No significant differences in the changes in maternal or fetal hemodynamic parameters from baseline to estimated time of peak Nicotine exposure were observed between those who smoked cigarettes and those who chewed Nicotine Gum. Conclusion Short-term use of Nicotine Gum delivers less Nicotine than usual cigarette smoking in pregnant women. Clinical Pharmacology & Therapeutics (1996) 59, 654–661; doi:
Arthur J. Garvey - One of the best experts on this subject based on the ideXlab platform.
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assigning dose of Nicotine Gum by time to first cigarette
Nicotine & Tobacco Research, 2013Co-Authors: Saul Shiffman, Mark A Sembower, Jeffrey M Rohay, Joe G Gitchell, Arthur J. GarveyAbstract:INTRODUCTION Nicotine Gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the Gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg Gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of Nicotine Gum dose by level of Nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg Gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg Gum was significant among light smokers (<25 CPD) with TTFC ≤ 30; 2-mg Gum was not. CONCLUSION This analysis suggests that assigning dose of Nicotine Gum based on TTFC is an effective and appropriate means of dose allocation.
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Assigning dose of Nicotine Gum by time to first cigarette.
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2012Co-Authors: Saul Shiffman, Mark A Sembower, Jeffrey M Rohay, Joe G Gitchell, Arthur J. GarveyAbstract:INTRODUCTION Nicotine Gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the Gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg Gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of Nicotine Gum dose by level of Nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg Gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg Gum was significant among light smokers (
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effect of compliance with Nicotine Gum dosing on weight gained during a quit attempt
Addiction, 2011Co-Authors: Stuart G. Ferguson, Saul Shiffman, Jeffrey M Rohay, Joseph G Gitchell, Arthur J. GarveyAbstract:Aim Using Nicotine Gum can reduce the amount of weight gained when quitting. Here we examine the relationship between weight gain and use of adequate amounts of Gum. To mitigate the confounders associated with correlational analyses, we contrast the effects of active Gum and placebo, and analyze outcomes prospectively. Design and setting Randomized double-blind placebo-controlled trial of Nicotine Gum. Participants were instructed to use nine to 15 pieces of Gum/day for the first 2 months of treatment. Participants Participants (n = 103) were randomized to either active (2 mg or 4 mg) or placebo Gum. Measurements We examined the effect on weight gain of the interaction between treatment (active versus placebo) and daily Gum use [－9 pieces/day (compliant use) versus < 9 pieces/day]. Findings After 30 days of abstinence, smokers treated with active Gum had not gained significantly less weight than those on placebo (1.1 kg versus 1.6 kg, P = 0.175). However, a significant compliance・treatment interaction was observed (P = 0.005): active Gum users who used －9 pieces/day during the first 14 days of treatment had gained less weight at follow-up (0.6 kg versus 1.6 kg for those who used <9 pieces/day, P = 0.017), but participants randomized to the placebo group saw no such benefit from compliant use. A similar compliance・treatment interaction (P = 0.046) was also observed when the effect of compliance was examined within active treatment (2 mg versus 4 mg). Conclusions When smokers are quitting, those who use more pieces of Nicotine Gum experience less weight gain in the first 30 days. This relationship is not seen for smokers on placebo Gum.
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Effect of compliance with Nicotine Gum dosing on weight gained during a quit attempt.
Addiction (Abingdon England), 2010Co-Authors: Stuart G. Ferguson, Saul Shiffman, Jeffrey M Rohay, Joseph G Gitchell, Arthur J. GarveyAbstract:Aim Using Nicotine Gum can reduce the amount of weight gained when quitting. Here we examine the relationship between weight gain and use of adequate amounts of Gum. To mitigate the confounders associated with correlational analyses, we contrast the effects of active Gum and placebo, and analyze outcomes prospectively. Design and setting Randomized double-blind placebo-controlled trial of Nicotine Gum. Participants were instructed to use nine to 15 pieces of Gum/day for the first 2 months of treatment. Participants Participants (n = 103) were randomized to either active (2 mg or 4 mg) or placebo Gum. Measurements We examined the effect on weight gain of the interaction between treatment (active versus placebo) and daily Gum use [－9 pieces/day (compliant use) versus < 9 pieces/day]. Findings After 30 days of abstinence, smokers treated with active Gum had not gained significantly less weight than those on placebo (1.1 kg versus 1.6 kg, P = 0.175). However, a significant compliance・treatment interaction was observed (P = 0.005): active Gum users who used －9 pieces/day during the first 14 days of treatment had gained less weight at follow-up (0.6 kg versus 1.6 kg for those who used
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Exercise as an adjunct to Nicotine Gum in treating tobacco dependence among women
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2008Co-Authors: Taru Kinnunen, Arthur J. Garvey, Robert F. Leeman, Tellervo Korhonen, Zandra N. Quiles, Donna Medaglia Terwal, L. Howard HartleyAbstract:This was the first randomized, controlled smoking cessation trial assessing the efficacy of an exercise intervention as an adjunct to Nicotine Gum therapy in comparison to both equal contact control and standard care control conditions. Sedentary female smokers aged 18-55 were provided with Nicotine Gum treatment along with brief behavioral counseling and were randomized into one of these three behavioral adjunct conditions. In the “intent-to-treat” sample (N=182), at end of treatment and at one-year follow up, there were clear, but non-significant, trends in univariate analyses in which the exercise and equal contact control conditions both had higher rates of abstinence than the standard care control. However, when adjusting for other predictors of relapse in a multiple logistic regression, both exercise and equal contact control showed an advantage over standard care control in avoiding early relapse (i.e., after 1 week). In a multivariate survival model adjusting for other predictors, the equal contact condition had a significantly lower likelihood of relapse compared to the standard care condition and there was a near significant trend in which exercise offered an advantage over standard care as well. While these findings suggest a slightly improved likelihood of abstinence with exercise compared with standard care, exercise did not differ from equal contact control in its efficacy. Potential explanations for these equivalent levels of efficacy and implications for the findings are discussed.
Jean-françois Etter - One of the best experts on this subject based on the ideXlab platform.
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Nicotine Gum treatment before smoking cessation: a randomized trial.
Archives of internal medicine, 2009Co-Authors: Jean-françois Etter, Philippe Huguelet, Thomas V. Perneger, Jacques CornuzAbstract:BACKGROUND: New ways of improving the efficacy of Nicotine therapy need to be explored. We tested whether starting Nicotine polacrilex Gum treatment 4 weeks before the quit date improved smoking abstinence rates compared with starting treatment on the quit date. METHODS: An open randomized trial of 314 daily smokers (mean, 23.7 cigarettes/d) enrolled through the Internet and by physicians in Switzerland from November 2005 to January 2007. In the precessation treatment group, participants received Nicotine polacrilex Gum (4 mg, unflavored) by mail for 4 weeks before and 8 weeks after their target quit date, and they were instructed to decrease their cigarette consumption by half before quitting. In the usual care group, participants received the same Nicotine Gum for 8 weeks after their quit date and were instructed to quit abruptly. Instructions were limited to a booklet sent by mail and access to a smoking cessation Web site. Results are expressed as self-reported abstinence rates at the end of treatment and as biochemically verified smoking abstinence (cotinine plus carbon monoxide) after 12 months. RESULTS: Eight weeks after the target quit date, self-reported 4-week abstinence rates were 41.6% in the precessation treatment group and 44.4% in the usual care group (P =.61). One year after the target quit date, biochemically verified 4-week smoking abstinence rates were 20.8% in the precessation treatment group and 19.4% in the usual care group (P =.76). CONCLUSION: Starting Nicotine Gum treatment 4 weeks before the target quit date was no more effective than starting treatment on the quit date.
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dependence on the Nicotine Gum in former smokers
Addictive Behaviors, 2009Co-Authors: Jean-françois EtterAbstract:We conducted an Internet survey in 2004-2007 in 526 daily users of the Nicotine Gum, to assess use of, and dependence on the Nicotine Gum in former smokers. We used modified versions of the Nicotine Dependence Syndrome Scale (NDSS-G), the Cigarette Dependence Scale (CDS-G) and the Fagerstrom Test (FTND-G). After 30 days, 155 participants (29%) indicated their Gum use. Higher dependence on the Gum predicted a lower chance of stopping using it at follow-up (odds ratio=0.36 for each standard deviation unit on CDS-G, p=0.001). More long-term (>3 months) than short-term (< or =3 months) users of the Gum agreed with: "I use the Nicotine Gum because I am addicted to it" (83% vs. 7%, p<.001), and fewer long-term users reported that they used the Gum to avoid relapsing to smoking (42% vs. 92%, p<.001). Long-term users had higher ratings of dependence on the Gum than short-term users, as assessed with NDSS-Gum, CDS-Gum and FTND-Gum (all p<.001). Most long-term users reported symptoms of dependence on the Nicotine Gum. Lower levels of dependence on the Gum predicted cessation of Gum use. However, long term use of the Nicotine Gum has no known serious adverse consequence, and may be beneficial if it prevents late relapse.
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Dependence on the Nicotine Gum in former smokers.
Addictive behaviors, 2008Co-Authors: Jean-françois EtterAbstract:article i nfo We conducted an Internet survey in 2004-2007 in 526 daily users of the Nicotine Gum, to assess use of, and dependence on the Nicotine Gum in former smokers. We used modified versions of the Nicotine Dependence Syndrome Scale (NDSS-G), the Cigarette Dependence Scale (CDS-G) and the Fagerstrom Test (FTND-G). After 30 days, 155 participants (29%) indicated their Gum use. Higher dependence on the Gum predicted a lower chance of stopping using it at follow-up (odds ratio=0.36 for each standard deviation unit on CDS-G, p=0.001). More long-term (N3 months) than short-term (b=3 months) users of the Gum agreed with: "I use the Nicotine Gum because I am addicted to it" (83% vs. 7%, pb.001), and fewer long-term users reported that they used the Gum to avoid relapsing to smoking (42% vs. 92%, pb.001). Long-term users had higher ratings of dependence on the Gum than short-term users, as assessed with NDSS-Gum, CDS-Gum and FTND-Gum (all pb.001). Most long-term users reported symptoms of dependence on the Nicotine Gum. Lower levels of dependence on the Gum predicted cessation of Gum use. However, long term use of the Nicotine Gum has no known serious adverse consequence, and may be beneficial if it prevents late relapse.
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Addiction to the Nicotine Gum in never smokers
BMC public health, 2007Co-Authors: Jean-françois EtterAbstract:Background Addiction to Nicotine Gum has never been described in never smokers or in never users of tobacco.
Vincent L. Sorrell - One of the best experts on this subject based on the ideXlab platform.
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acute changes in left ventricular diastolic function cigarette smoking versus Nicotine Gum
Clinical Cardiology, 2006Co-Authors: Matthew I. Gembala, Firas A. Ghanem, Christopher A. Mann, Vincent L. SorrellAbstract:University of Arizona, Tucson, Arizona; *Departments of Internal Medicine, Divisions of Cardiology, East Carolina University Br odySchool of Medicine, Greenville, North Carolina, USASummaryBackground: Echocardiographic evidence of diastolic dys-function has been demonstrated during acute cigarette smok-ing in patients with coronary artery disease. Similar studies inhealthy patients have shown conflicting results. Furthermore,it is unclear whether Nicotine or some other cigarette-relatedsubstance is responsible for these observations. Hypothesis: The purpose of the study was to confirm or re-fute acute effects of cigarette smoking on diastolic function inhealthy patients and to compare diastolic effects of a cigaretteto smokeless Nicotine delivery (Nicotine Gum).Methods: In all, 27 healthy volunteers were self-assignedinto one of two cohorts. A baseline echocardiogram was per-formed in all patients. The first cohort proceeded to smoke acigarette and the second to chew a piece of Nicotine Gum. With-in minutes after exposure, another echocardiogram was per-formed. Traditional measures of diastolic function were com-pared before and after substance exposure by paired t-tests. Results: The cigarette cohort showed echocardiographicevidence of diastolic dysfunction after smoking. The E:A ratio(time integral) decreased from 2.95 to 2.22 (p<0.002). Atrialreversal pulmonary velocity, atrial reversal duration, and colorflow propagation all showed statistically significant alterations(p<0.05). The Nicotine Gum cohort showed no change in tra-ditional diastolic parameters. Conclusions: Diastolic function is impaired during acuteexposure to cigarette smoke but unchanged after exposure toNicotine Gum. It is therefore unlikely that Nicotine alone is re-sponsible for cigarette-induced acute diastolic dysfunction. Key words: cigarette smoking, diastolic function, Dopplerechocardiography, NicotineIntroductionIn clinical practice, smokers often complain of decreasedexercise tolerance. Often, the cardiovascular and pulmonarywork-up fails to show significant disease. Since diastolic func-tion is a major component of exercise tolerance, it follows thatcigarette exposure may affect diastolic function in these pa-tients. Previous studies have demonstrated a relationship be-tween cigarette smoking and acute echocardiographic evi-dence of diastolic dysfunction in patients with coronarydisease.
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Acute changes in left ventricular diastolic function: cigarette smoking versus Nicotine Gum.
Clinical cardiology, 2006Co-Authors: Matthew I. Gembala, Firas A. Ghanem, Christopher A. Mann, Vincent L. SorrellAbstract:University of Arizona, Tucson, Arizona; *Departments of Internal Medicine, Divisions of Cardiology, East Carolina University Br odySchool of Medicine, Greenville, North Carolina, USASummaryBackground: Echocardiographic evidence of diastolic dys-function has been demonstrated during acute cigarette smok-ing in patients with coronary artery disease. Similar studies inhealthy patients have shown conflicting results. Furthermore,it is unclear whether Nicotine or some other cigarette-relatedsubstance is responsible for these observations. Hypothesis: The purpose of the study was to confirm or re-fute acute effects of cigarette smoking on diastolic function inhealthy patients and to compare diastolic effects of a cigaretteto smokeless Nicotine delivery (Nicotine Gum).Methods: In all, 27 healthy volunteers were self-assignedinto one of two cohorts. A baseline echocardiogram was per-formed in all patients. The first cohort proceeded to smoke acigarette and the second to chew a piece of Nicotine Gum. With-in minutes after exposure, another echocardiogram was per-formed. Traditional measures of diastolic function were com-pared before and after substance exposure by paired t-tests. Results: The cigarette cohort showed echocardiographicevidence of diastolic dysfunction after smoking. The E:A ratio(time integral) decreased from 2.95 to 2.22 (p
Saul Shiffman - One of the best experts on this subject based on the ideXlab platform.
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Effectiveness of Nicotine Gum in preventing lapses in the face of temptation to smoke among non-daily smokers: a secondary analysis.
Addiction (Abingdon England), 2020Co-Authors: Saul Shiffman, Stuart G. Ferguson, Jason Mao, Sarah M. Scholl, Donald Hedeker, Hilary A. TindleAbstract:Background and aims: Non-daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of Nicotine Gum with placebo on quitting smoking in non-daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using Nicotine Gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations. Design: Within a 6-week randomized, placebo-controlled clinical trial of Nicotine Gum, analyses contrasted the outcome of temptation episodes where Gum was or was not used. Setting: Smoking cessation research clinic in Pittsburgh, PA, USA. Participants: A total of 255 adult ITS (131 Nicotine Gum, 124 placebo) seeking help for smoking cessation. Intervention: Nicotine Gum (2 mg) versus placebo for up to 8 weeks, with as-needed dosing instructions. Measurements: Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting Gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable. Findings: Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant Gum use × active treatment interaction (P = 0.0009). Using Nicotine Gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22-0.94]; when Gum was not used, the assigned Gum condition made no significant difference (OR = 1.53; 0.78-3.01; Bayes factor = 0.14). The Nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06). Conclusions: When used in response to temptation to smoke, 2 mg Nicotine Gum can help to prevent lapses among non-daily smokers.
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Using Nicotine Gum to Assist Nondaily Smokers in Quitting: A Randomized Clinical Trial
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2019Co-Authors: Saul Shiffman, Stuart G. Ferguson, Jason Mao, Sarah M. Scholl, Donald Hedeker, Brian A. Primack, Hilary A. TindleAbstract:Introduction: Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for Nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of Nicotine Gum, used to prevent or react to situational temptations, for helping ITS quit. Methods: ITS (smoking 4–27 days/month) seeking help quitting were randomized to 2 mg Nicotine Gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day pointprevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects. Results: Nicotine Gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active Gum and 5.3% for placebo (AOR = 1.39, 0.58–3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active Gum on some outcomes. Gum use was low, starting at 1 Gum per day on average and declining over time. Conclusions: Nicotine Gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence. Implications: Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS’ smoking is motivated by Nicotine-seeking, a theoretically and empirically derived situational approach to using acute Nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.
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assigning dose of Nicotine Gum by time to first cigarette
Nicotine & Tobacco Research, 2013Co-Authors: Saul Shiffman, Mark A Sembower, Jeffrey M Rohay, Joe G Gitchell, Arthur J. GarveyAbstract:INTRODUCTION Nicotine Gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the Gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg Gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of Nicotine Gum dose by level of Nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg Gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg Gum was significant among light smokers (<25 CPD) with TTFC ≤ 30; 2-mg Gum was not. CONCLUSION This analysis suggests that assigning dose of Nicotine Gum based on TTFC is an effective and appropriate means of dose allocation.
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Assigning dose of Nicotine Gum by time to first cigarette.
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2012Co-Authors: Saul Shiffman, Mark A Sembower, Jeffrey M Rohay, Joe G Gitchell, Arthur J. GarveyAbstract:INTRODUCTION Nicotine Gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the Gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg Gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of Nicotine Gum dose by level of Nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg Gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg Gum was significant among light smokers (
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effect of compliance with Nicotine Gum dosing on weight gained during a quit attempt
Addiction, 2011Co-Authors: Stuart G. Ferguson, Saul Shiffman, Jeffrey M Rohay, Joseph G Gitchell, Arthur J. GarveyAbstract:Aim Using Nicotine Gum can reduce the amount of weight gained when quitting. Here we examine the relationship between weight gain and use of adequate amounts of Gum. To mitigate the confounders associated with correlational analyses, we contrast the effects of active Gum and placebo, and analyze outcomes prospectively. Design and setting Randomized double-blind placebo-controlled trial of Nicotine Gum. Participants were instructed to use nine to 15 pieces of Gum/day for the first 2 months of treatment. Participants Participants (n = 103) were randomized to either active (2 mg or 4 mg) or placebo Gum. Measurements We examined the effect on weight gain of the interaction between treatment (active versus placebo) and daily Gum use [－9 pieces/day (compliant use) versus < 9 pieces/day]. Findings After 30 days of abstinence, smokers treated with active Gum had not gained significantly less weight than those on placebo (1.1 kg versus 1.6 kg, P = 0.175). However, a significant compliance・treatment interaction was observed (P = 0.005): active Gum users who used －9 pieces/day during the first 14 days of treatment had gained less weight at follow-up (0.6 kg versus 1.6 kg for those who used <9 pieces/day, P = 0.017), but participants randomized to the placebo group saw no such benefit from compliant use. A similar compliance・treatment interaction (P = 0.046) was also observed when the effect of compliance was examined within active treatment (2 mg versus 4 mg). Conclusions When smokers are quitting, those who use more pieces of Nicotine Gum experience less weight gain in the first 30 days. This relationship is not seen for smokers on placebo Gum.
