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Richard D Hurt - One of the best experts on this subject based on the ideXlab platform.
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Effect of High-Dose Nicotine Patch Therapy on Tobacco Withdrawal Symptoms Among Smokeless Tobacco Users
Nicotine & Tobacco Research, 2015Co-Authors: Jon O. Ebbert, Lowell C Dale, Ivana T Croghan, Thomas P. Moyer, Darrell R. Schroeder, Christi A. Patten, Richard D HurtAbstract:: No pharmacotherapies have been shown to increase long-term (> or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose Nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose Nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to Nicotine Patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and Nicotine toxicity were obtained with an electronic diary. During the first week of Nicotine Patch therapy, we observed a dose-response relationship such that higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of Nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose Nicotine Patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose Nicotine Patch therapy is safe and well tolerated in this population of tobacco users.
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A randomized phase II clinical trial of high-dose Nicotine Patch therapy for smokeless tobacco users.
Nicotine & Tobacco Research, 2013Co-Authors: Jon O. Ebbert, Ivana T Croghan, Darrell R. Schroeder, Richard D HurtAbstract:Introduction: Nicotine Patch therapy has not been shown to be efficacious for increasing long-term (≥6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Higher doses of Nicotine Patch therapy may be needed to increase tobacco abstinence rates in this population of tobacco users.
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Nicotine Patch use in pregnant smokers: smoking abstinence and delivery outcomes
Journal of Maternal-fetal & Neonatal Medicine, 2009Co-Authors: Darrell R. Schroeder, Richard D Hurt, Kenneth P Offord, Ivana T Croghan, Kirk D Ramin, P. L. Ogburn, Thomas P. MoyerAbstract:Objective: To describe smoking abstinence and fetal effects of pregnant smokers who received 8 weeks of Nicotine Patch therapy. Methods: One-sample study of 21 pregnant women smoking ≥ 15 cigarettes/day during their third trimester of pregnancy despite physician advice to stop. Nicotine Patch therapy (22 mg/24 h) was initiated during the first day of a 4-day in-hospital study and continued for a total of 8 weeks. Subjects returned weekly until delivery, at 4 weeks after delivery, and at 6 and 12 months after Patch therapy. Fetal growth and well-being were assessed using ultrasound examinations and non-stress tests. Results: Eight of 21 subjects completed all 8 weeks of Patch therapy according to the protocol. Five subjects (24%) discontinued using the Nicotine Patch, owing to adverse skin reactions. There were eight subjects (38%) who were biochemically confirmed abstinent from smoking at the time of delivery; of these, seven were continuously abstinent from the start of Patch therapy. Centile weight for ...
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Nicotine Percentage Replacement Among Smokeless Tobacco Users with Nicotine Patch
Drug and Alcohol Dependence, 2007Co-Authors: Jon O. Ebbert, Lowell C Dale, Jason A. Post, Thomas P. Moyer, Darrell R. Schroeder, Richard D HurtAbstract:Abstract To obtain preliminary evidence on the safety and efficacy of high dose Nicotine Patch therapy among smokeless tobacco (ST) users who consume ≥3 cans of ST per week, we conducted a randomized, placebo-controlled clinical trial with 42 ST users randomized to Nicotine Patch doses of 21, 42, and 63 mg/day or placebo. Serum Nicotine concentrations were measured during ad libitum ST use and Nicotine replacement therapy, and percentages of Nicotine replacement were calculated. We observed substantial inter-subject variability in Nicotine concentrations with ad lib ST use. The mean percentage replacement of ad lib ST use serum Nicotine concentrations approximated 100% with the 42 mg/day Patch dose (mean ± S.D., 98.4% ± 45%). Dosing with the 21 mg/day Nicotine Patch was associated with mean “under-replacement” (53.2% ± 17.1%), and the 63 mg/day Nicotine was associated with mean “over-replacement” (159.2% ± 121.9%). We observed symptoms of nausea consistent with Nicotine toxicity in two subjects in the 63 mg/day group while no subjects in the 42 mg/day reported these symptoms. We conclude that the use of 42 mg/day Nicotine Patch therapy is safe and should be considered as initial therapy in the clinical setting among ST users who use ≥3 cans/week.
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Nicotine Patch therapy based on smoking rate followed by bupropion for prevention of relapse to smoking
Journal of Clinical Oncology, 2003Co-Authors: Richard D Hurt, Ivana T Croghan, James E Krook, Charles L Loprinzi, Jeff A Sloan, Paul J Novotny, Carl G Kardinal, James A Knost, Maria Tria Tirona, Ferdinand AddoAbstract:Purpose: To determine whether (1) tailored Nicotine Patch therapy that is based on smoking rate can be carried out in a multisite oncology investigative group practice setting, (2) long-term use of bupropion reduces the rate of relapse to smoking in smokers who stop smoking with Nicotine Patch therapy, and (3) bupropion can initiate smoking abstinence among smokers who have failed to stop smoking after Nicotine Patch therapy. Participants and Methods: Fourteen North Central Cancer Treatment Group sites recruited generally healthy adult smokers from the general population for Nicotine Patch therapy and based the Patch dosage on smoking rates. At completion of Nicotine Patch therapy, nonsmoking participants were eligible to be assigned to bupropion or placebo for 6 months (for relapse prevention). and smoking participants were eligible to be assigned to bupropion or placebo for 8 weeks of treatment. Results: Of 578 subjects, 31% were abstinent from smoking at the end of Nicotine Patch therapy. Of those subj...
R. West - One of the best experts on this subject based on the ideXlab platform.
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neuropsychiatric safety and efficacy of varenicline bupropion and Nicotine Patch in smokers with and without psychiatric disorders eagles a double blind randomised placebo controlled clinical trial
The Lancet, 2016Co-Authors: Robert M Anthenelli, R. West, Neal L Benowitz, Lisa St Aubin, Thomas Mcrae, David Lawrence, John A Ascher, Cristina Russ, Alok Krishen, Eden A EvinsAbstract:Summary Background Substantial concerns have been raised about the neuropsychiatric safety of the smoking cessation medications varenicline and bupropion. Their efficacy relative to Nicotine Patch largely relies on indirect comparisons, and there is limited information on safety and efficacy in smokers with psychiatric disorders. We compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with Nicotine Patch and placebo in smokers with and without psychiatric disorders. Methods We did a randomised, double-blind, triple-dummy, placebo-controlled and active-controlled (Nicotine Patch; 21 mg per day with taper) trial of varenicline (1 mg twice a day) and bupropion (150 mg twice a day) for 12 weeks with 12-week non-treatment follow-up done at 140 centres (clinical trial centres, academic centres, and outpatient clinics) in 16 countries between Nov 30, 2011, and Jan 13, 2015. Participants were motivated-to-quit smokers with and without psychiatric disorders who received brief cessation counselling at each visit. Randomisation was computer generated (1:1:1:1 ratio). Participants, investigators, and research personnel were masked to treatment assignments. The primary endpoint was the incidence of a composite measure of moderate and severe neuropsychiatric adverse events. The main efficacy endpoint was biochemically confirmed continuous abstinence for weeks 9–12. All participants randomly assigned were included in the efficacy analysis and those who received treatment were included in the safety analysis. The trial is registered at ClinicalTrials.gov (number NCT01456936) and is now closed. Findings 8144 participants were randomly assigned, 4116 to the psychiatric cohort (4074 included in the safety analysis) and 4028 to the non-psychiatric cohort (3984 included in the safety analysis). In the non-psychiatric cohort, 13 (1·3%) of 990 participants reported moderate and severe neuropsychiatric adverse events in the varenicline group, 22 (2·2%) of 989 in the bupropion group, 25 (2·5%) of 1006 in the Nicotine Patch group, and 24 (2·4%) of 999 in the placebo group. The varenicline–placebo and bupropion–placebo risk differences (RDs) for moderate and severe neuropsychiatric adverse events were −1·28 (95% CI −2·40 to −0·15) and −0·08 (−1·37 to 1·21), respectively; the RDs for comparisons with Nicotine Patch were −1·07 (−2·21 to 0·08) and 0·13 (−1·19 to 1·45), respectively. In the psychiatric cohort, moderate and severe neuropsychiatric adverse events were reported in 67 (6·5%) of 1026 participants in the varenicline group, 68 (6·7%) of 1017 in the bupropion group, 53 (5·2%) of 1016 in the Nicotine Patch group, and 50 (4·9%) of 1015 in the placebo group. The varenicline–placebo and bupropion–placebo RDs were 1·59 (95% CI −0·42 to 3·59) and 1·78 (−0·24 to 3·81), respectively; the RDs versus Nicotine Patch were 1·22 (−0·81 to 3·25) and 1·42 (−0·63 to 3·46), respectively. Varenicline-treated participants achieved higher abstinence rates than those on placebo (odds ratio [OR] 3·61, 95% CI 3·07 to 4·24), Nicotine Patch (1·68, 1·46 to 1·93), and bupropion (1·75, 1·52 to 2·01). Those on bupropion and Nicotine Patch achieved higher abstinence rates than those on placebo (OR 2·07 [1·75 to 2·45] and 2·15 [1·82 to 2·54], respectively). Across cohorts, the most frequent adverse events by treatment group were nausea (varenicline, 25% [511 of 2016 participants]), insomnia (bupropion, 12% [245 of 2006 participants]), abnormal dreams (Nicotine Patch, 12% [251 of 2022 participants]), and headache (placebo, 10% [199 of 2014 participants]). Efficacy treatment comparison did not differ by cohort. Interpretation The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to Nicotine Patch or placebo. Varenicline was more effective than placebo, Nicotine Patch, and bupropion in helping smokers achieve abstinence, whereas bupropion and Nicotine Patch were more effective than placebo. Funding Pfizer and GlaxoSmithKline.
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Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to Nicotine Patch therapy
ADDICTION, 2005Co-Authors: R. WestAbstract:Aim To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among Nicotine Patch users.Design Two-group randomized controlled trial.Setting World Wide Web in England and Republic of Ireland.Participants A total of 3971 subjects who purchased a particular brand of Nicotine Patch and logged-on to use a free web-based behavioral support program.Intervention Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials.Measurements Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up.Findings Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition.Conclusions The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with Nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.
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Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to Nicotine Patch therapy
Addiction, 2005Co-Authors: Victor J. Strecher, Saul Shiffman, R. WestAbstract:AIM: To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among Nicotine Patch users. DESIGN: Two-group randomized controlled trial. SETTING: World Wide Web in England and Republic of Ireland. PARTICIPANTS: A total of 3971 subjects who purchased a particular brand of Nicotine Patch and logged-on to use a free web-based behavioral support program. INTERVENTION: Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials. MEASUREMENTS: Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up. FINDINGS: Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition. CONCLUSIONS: The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with Nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.
Ivana T Croghan - One of the best experts on this subject based on the ideXlab platform.
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Effect of High-Dose Nicotine Patch Therapy on Tobacco Withdrawal Symptoms Among Smokeless Tobacco Users
Nicotine & Tobacco Research, 2015Co-Authors: Jon O. Ebbert, Lowell C Dale, Ivana T Croghan, Thomas P. Moyer, Darrell R. Schroeder, Christi A. Patten, Richard D HurtAbstract:: No pharmacotherapies have been shown to increase long-term (> or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose Nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose Nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to Nicotine Patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and Nicotine toxicity were obtained with an electronic diary. During the first week of Nicotine Patch therapy, we observed a dose-response relationship such that higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of Nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose Nicotine Patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose Nicotine Patch therapy is safe and well tolerated in this population of tobacco users.
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A randomized phase II clinical trial of high-dose Nicotine Patch therapy for smokeless tobacco users.
Nicotine & Tobacco Research, 2013Co-Authors: Jon O. Ebbert, Ivana T Croghan, Darrell R. Schroeder, Richard D HurtAbstract:Introduction: Nicotine Patch therapy has not been shown to be efficacious for increasing long-term (≥6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Higher doses of Nicotine Patch therapy may be needed to increase tobacco abstinence rates in this population of tobacco users.
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Nicotine Patch use in pregnant smokers: smoking abstinence and delivery outcomes
Journal of Maternal-fetal & Neonatal Medicine, 2009Co-Authors: Darrell R. Schroeder, Richard D Hurt, Kenneth P Offord, Ivana T Croghan, Kirk D Ramin, P. L. Ogburn, Thomas P. MoyerAbstract:Objective: To describe smoking abstinence and fetal effects of pregnant smokers who received 8 weeks of Nicotine Patch therapy. Methods: One-sample study of 21 pregnant women smoking ≥ 15 cigarettes/day during their third trimester of pregnancy despite physician advice to stop. Nicotine Patch therapy (22 mg/24 h) was initiated during the first day of a 4-day in-hospital study and continued for a total of 8 weeks. Subjects returned weekly until delivery, at 4 weeks after delivery, and at 6 and 12 months after Patch therapy. Fetal growth and well-being were assessed using ultrasound examinations and non-stress tests. Results: Eight of 21 subjects completed all 8 weeks of Patch therapy according to the protocol. Five subjects (24%) discontinued using the Nicotine Patch, owing to adverse skin reactions. There were eight subjects (38%) who were biochemically confirmed abstinent from smoking at the time of delivery; of these, seven were continuously abstinent from the start of Patch therapy. Centile weight for ...
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Nicotine Patch therapy based on smoking rate followed by bupropion for prevention of relapse to smoking
Journal of Clinical Oncology, 2003Co-Authors: Richard D Hurt, Ivana T Croghan, James E Krook, Charles L Loprinzi, Jeff A Sloan, Paul J Novotny, Carl G Kardinal, James A Knost, Maria Tria Tirona, Ferdinand AddoAbstract:Purpose: To determine whether (1) tailored Nicotine Patch therapy that is based on smoking rate can be carried out in a multisite oncology investigative group practice setting, (2) long-term use of bupropion reduces the rate of relapse to smoking in smokers who stop smoking with Nicotine Patch therapy, and (3) bupropion can initiate smoking abstinence among smokers who have failed to stop smoking after Nicotine Patch therapy. Participants and Methods: Fourteen North Central Cancer Treatment Group sites recruited generally healthy adult smokers from the general population for Nicotine Patch therapy and based the Patch dosage on smoking rates. At completion of Nicotine Patch therapy, nonsmoking participants were eligible to be assigned to bupropion or placebo for 6 months (for relapse prevention). and smoking participants were eligible to be assigned to bupropion or placebo for 8 weeks of treatment. Results: Of 578 subjects, 31% were abstinent from smoking at the end of Nicotine Patch therapy. Of those subj...
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Nicotine Patch therapy in 101 adolescent smokers efficacy withdrawal symptom relief and carbon monoxide and plasma cotinine levels
JAMA Pediatrics, 2000Co-Authors: Richard D Hurt, Ivana T Croghan, Troy D Wolter, Gary A Croghan, Scott D Beede, Christi A. PattenAbstract:Objectives To determine the efficacy of Nicotine Patch therapy in adolescents who want to stop smoking and to assess biochemical markers of smoking and Nicotine intake. Design Nonrandomized, open-label trial using a 15 mg/16 h Patch. Setting Two midwestern cities. Subjects One hundred one adolescents aged 13 through 17 years smoking at least 10 cigarettes per day (cpd). Intervention Six weeks of Nicotine Patch therapy and follow-up visits at 12 weeks and 6 months. Main Outcome Measures Self-reported smoking abstinence verified by expired-air carbon monoxide (CO) level of no more than 8 ppm, Nicotine withdrawal symptoms, and plasma cotinine level. Results Forty-one participants were female (mean [± SD] age, 16.5 [± 1.1] years). Median baseline smoking rate was 20.0 cpd (range, 10-40 cpd). Biochemically confirmed point prevalence smoking abstinence was 10.9% (11/101) at 6 weeks and 5.0% (5/101) at 6 months. The mean (± SD) plasma cotinine level at baseline was 1510.9 ± 732.7 nmol/L; for nonsmoking subjects at weeks 3 and 6, 607.8 ± 386.2 and 710.0 ± 772.5 nmol/L, respectively. Plasma cotinine levels were correlated with CO levels at baseline ( r = 0.27; P = .006), week 3 ( r = 0.34; P = .004), and week 6 ( r = 0.26; P = .03) and with mean cigarettes smoked per day during weeks 3 ( r = 0.24; P = .04) and 6 ( r = 0.30; P = .02). Mean smoking rates decreased significantly during the study, an effect that lessened at 12 weeks and 6 months. Conclusions Nicotine Patch therapy plus minimal behavioral intervention does not appear to be effective for treatment of adolescent smokers. Plasma cotinine and CO levels appear to be valid measures of smoking rates during the cessation process, but not at baseline. Smoking rates were reduced throughout the study. Additional pharmacological and behavioral treatments should be considered in adolescent smokers.
Lowell C Dale - One of the best experts on this subject based on the ideXlab platform.
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Effect of High-Dose Nicotine Patch Therapy on Tobacco Withdrawal Symptoms Among Smokeless Tobacco Users
Nicotine & Tobacco Research, 2015Co-Authors: Jon O. Ebbert, Lowell C Dale, Ivana T Croghan, Thomas P. Moyer, Darrell R. Schroeder, Christi A. Patten, Richard D HurtAbstract:: No pharmacotherapies have been shown to increase long-term (> or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose Nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose Nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to Nicotine Patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and Nicotine toxicity were obtained with an electronic diary. During the first week of Nicotine Patch therapy, we observed a dose-response relationship such that higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher Nicotine Patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of Nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose Nicotine Patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose Nicotine Patch therapy is safe and well tolerated in this population of tobacco users.
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a randomized controlled trial of adding the Nicotine Patch to rimonabant for smoking cessation efficacy safety and weight gain
Addiction, 2009Co-Authors: Nancy A Rigotti, Lowell C Dale, David Gonzales, Daniel A Lawrence, Yuchiao ChangAbstract:Aims Because smoking cessation rates might be improved by combining drugs and by reducing post-cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the Nicotine Patch to rimonabant, a cannabanoid type-1 receptor antagonist that reduces body weight. Design Randomized double-blind placebo-controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open-label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a Nicotine Patch (n = 369) or placebo Patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2-week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4-week continuous abstinence at end-of-treatment (weeks 6–9; primary end-point); 7-day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus Nicotine Patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end-of-treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight-concerned smokers. Serious adverse event rates did not differ between groups. Depression- and anxiety-related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a Nicotine Patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post-cessation weight gain in either group, even among weight-concerned smokers, during drug treatment.
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Nicotine Percentage Replacement Among Smokeless Tobacco Users with Nicotine Patch
Drug and Alcohol Dependence, 2007Co-Authors: Jon O. Ebbert, Lowell C Dale, Jason A. Post, Thomas P. Moyer, Darrell R. Schroeder, Richard D HurtAbstract:Abstract To obtain preliminary evidence on the safety and efficacy of high dose Nicotine Patch therapy among smokeless tobacco (ST) users who consume ≥3 cans of ST per week, we conducted a randomized, placebo-controlled clinical trial with 42 ST users randomized to Nicotine Patch doses of 21, 42, and 63 mg/day or placebo. Serum Nicotine concentrations were measured during ad libitum ST use and Nicotine replacement therapy, and percentages of Nicotine replacement were calculated. We observed substantial inter-subject variability in Nicotine concentrations with ad lib ST use. The mean percentage replacement of ad lib ST use serum Nicotine concentrations approximated 100% with the 42 mg/day Patch dose (mean ± S.D., 98.4% ± 45%). Dosing with the 21 mg/day Nicotine Patch was associated with mean “under-replacement” (53.2% ± 17.1%), and the 63 mg/day Nicotine was associated with mean “over-replacement” (159.2% ± 121.9%). We observed symptoms of nausea consistent with Nicotine toxicity in two subjects in the 63 mg/day group while no subjects in the 42 mg/day reported these symptoms. We conclude that the use of 42 mg/day Nicotine Patch therapy is safe and should be considered as initial therapy in the clinical setting among ST users who use ≥3 cans/week.
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Nicotine Patch therapy for smoking cessation in recovering alcoholics
Addiction, 1995Co-Authors: Richard D Hurt, Lowell C Dale, Kenneth P Offord, Ivana T Croghan, James Taylor Hays, Leigh C GomezdahlAbstract:In a post hoc analysis of prior Nicotine Patch studies, we analysed findings in 357 subjects (43 recovering alcoholics, 314 non-alcoholics) to determine if recovering alcoholic smokers were more Nicotine dependent than non-alcoholics and whether the efficacy of Nicotine Patch therapy was comparable. The Self-Administered Alcoholism Screening Test was used to identify recovering alcoholics. Recovering alcoholics had significantly higher mean smoking rates (cigarettes per day), Fagerstrom scores and baseline serum Nicotine and cotinine than non-alcoholics. Among a subset of 240 subjects with a comparable treatment protocol, smoking cessation rates at the end of Nicotine Patch therapy were similar in recovering alcoholics (46%) and non-alcoholics (47%) receiving active 22 mg Patches but higher than the respective placebo groups (17% and 19%). The 1-year rate was significantly (p = 0.005) higher in the non-alcoholic group assigned to an active Patch (31%) compared to placebo (14%). For recovering alcoholics, the rates were lower and not significantly different (active 0%, placebo 11%). Recovering alcoholic smokers are likely to be more Nicotine dependent than non-alcoholic smokers but can achieve comparable short-term cessation rates with Nicotine Patch therapy. Use of an objective, validated measure of alcohol dependence is indicated in clinical trials when it is desirable to know whether the subjects are active or recovering alcoholics.
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high dose Nicotine Patch therapy percentage of replacement and smoking cessation
JAMA, 1995Co-Authors: Lowell C Dale, Richard D Hurt, Kenneth P Offord, Ivana T Croghan, George M Lawson, Darrell R. SchroederAbstract:Objective. —To assess the level of Nicotine replacement, evidence of Nicotine toxicity, and withdrawal symptom relief with placebo and 11-, 22-, and 44-mg/d doses of transdermal Nicotine. A secondary objective was to assess short- and long-term smoking cessation rates. Design. —Randomized, double-blind, placebo-controlled inpatient/outpatient trial. Subjects. —Seventy-one cigarette smokers stratified according to light (n=23), moderate (n=24), and heavy (n=24) smoking rates. Interventions. —After baseline measures were obtained, subjects were randomly assigned to placebo or an 11-, 22-, or 44-mg/d dose of transdermal Nicotine and admitted to a special hospital unit for intensive inpatient treatment of Nicotine dependence. During the 6-day inpatient stay, daily Nicotine and cotinine levels were determined from trough and peak blood samples. Outpatient Patch therapy continued for 7 weeks following the hospital stay, and those initially assigned to placebo were randomly assigned to 11 or 22 mg/d. At week 4, the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d. Main Outcome Measures. —Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during Patch therapy by the corresponding baseline levels. Abstinence from smoking was verified by expired air carbon monoxide. Withdrawal symptoms and Nicotine toxicity were assessed daily through questionnaires during the inpatient stay. Follow-up visits were at 3,6,9, and 12 months. Results. —There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels (rs=0.39,rs=0.45;P Conclusion. —A 44-mg/d dose of Nicotine Patch therapy appears to be safe for use in heavy smokers. Cigarette smoking rates can be used to estimate the initial Nicotine Patch dose. Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of Nicotine replacement. Withdrawal symptom relief can be improved with more complete Nicotine replacement. Achieving a greater percentage of Nicotine replacement may increase the efficacy of Nicotine Patch therapy. (JAMA. 1995;274:1353-1358)
Scott J Leischow - One of the best experts on this subject based on the ideXlab platform.
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late term smoking cessation despite initial failure an evaluation of bupropion sustained release Nicotine Patch combination therapy and placebo
Clinical Therapeutics, 2001Co-Authors: Brenda D Jamerson, Michael C. Fiore, Douglas E. Jorenby, Mitchell A Nides, Stephen I Rennard, Andrew J Johnston, Rafe M J Donahue, Peter Garrett, Scott J LeischowAbstract:Objective: The purpose of this study was to evaluate the efficacy of long-term use of bupropion sustained release (SR), the Nicotine Patch, and the combination of these 2 treatments in patients who initially failed treatment. Methods: This was a post hoc analysis of a multicenter, double-blind, randomized, placebo-controlled clinical trial in 893 smokers. Patients were randomly assigned to 9 weeks of treatment with placebo (n = 160), bupropion SR (n = 244), Nicotine Patch (n = 244), or a combination of Nicotine Patch and bupropion SR (n = 245). The study was originally designed with a follow-up period of 52 weeks. In this analysis, short-term success was defined as smoking cessation after 14 or 21 days of therapy and long-term success was defined as smoking cessation after > 21 days of therapy. Patients who did not achieve short-term success were evaluated for long-term success at week 9 (end of treatment), 6 months, and 1 year after the start of the study. Results: The mean age of the smokers was 44 years. The majority (93%) of patients were white, and 52% were female. The study subjects smoked an average of 27 cigarettes per day. Among the 467 patients who initially failed treatment in the first 3 weeks, treatment with bupropion SR alone and in combination with the Nicotine Patch produced significant increases in successful smoking cessation rates from weeks 4 to 9 (19% bupropion SR or combination, 7% Nicotine Patch, 7% placebo), at month 6 (11% bupropion SR, 13% combination, 2% Nicotine Patch, 3% placebo), and at month 12 (10% bupropion SR, 7% combination, 2% Nicotine Patch, 1% placebo) (P < 0.05 for bupropion SR and combination vs Nicotine Patch or placebo). Conclusion: Among patients who initially failed treatment, continued therapy with bupropion SR, either alone or in combination with the Nicotine Patch, resulted in significantly higher short- and long-term smoking cessation rates than treatment with the Nicotine Patch alone or placebo.
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a controlled trial of sustained release bupropion a Nicotine Patch or both for smoking cessation
The New England Journal of Medicine, 1999Co-Authors: Douglas E. Jorenby, Stevens S. Smith, Scott J Leischow, Mitchell A Nides, Stephen I Rennard, Andrew J Johnston, Arlene R Hughes, Myra L Muramoto, David M Daughton, Kimberli DoanAbstract:Background and Methods Use of Nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a Nicotine Patch (244 subjects), bupropion and a Nicotine Patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of Nicotine-Patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. Results The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the Nicotine-Patch group, 30.3 percent in the bupropion group (P<0.001), and 35.5 percent in the group given bupropion and the Nicotine Patch (P<0.001). B...
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A controlled trial of sustained-release bupropion, a Nicotine Patch, or both for smoking cessation
The New England Journal of Medicine, 1999Co-Authors: Douglas E. Jorenby, Stevens S. Smith, Scott J Leischow, Mitchell A Nides, Stephen I Rennard, Arlene R Hughes, Myra L Muramoto, David M Daughton, J. Andrew Johnston, Kimberli DoanAbstract:Background and Methods Use of Nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a Nicotine Patch (244 subjects), bupropion and a Nicotine Patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of Nicotine-Patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. Results The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the Nicotine-Patch group, 30.3 percent in the bupropion group (P
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effectiveness of a 16 hour transdermal Nicotine Patch in a medical practice setting without intensive group counseling
JAMA Internal Medicine, 1993Co-Authors: David P L Sachs, Urbain Sawe, Scott J LeischowAbstract:Background: To determine the effectiveness of a 16-hour transdermal Nicotine Patch in assisting smokers to stop smoking, when used in a primary medical practice model. Methods: A single-site, randomized, double-blind, outpatient, parallel-group, placebo-controlled trial consisting of 220 regular, otherwise healthy cigarette smokers. Patients participated in a 12-week Patch treatment phase plus a 6-week tapering phase. A standard medical office model of physician intervention, such as could easily be employed by any primary care physician, without need for any special psychological services, training, or skills, was the behavioral intervention. Results: Sustained abstinence, determined at each visit by absolutely no cigarette use, carbon monoxide level of 9 ppm or less, and serum cotinine level of 15 ng/mL or less (after week 18), was significantly greater for those patients receiving the active Nicotine Patch than for those receiving the placebo Patch: the percent of patients not smoking at 6,12,18,26, and 52 weeks was 61% vs 35%, 45% vs 26%, 41% vs 16%, 34% vs 12%, and 25% vs 9%, respectively (P Conclusions: Nicotine replacement therapy via a 16-hour transdermal Nicotine Patch provided safe and effective treatment for tobacco-dependent patients. One-year sustained nonsmoking rates were nearly three times higher in the active than in the placebo condition, when the Patch was used in an easily applicable standard medical practice setting, without the need for psychological interventions. This outcome was as good as or better than results achieved by Nicotine Patches using behavior modification or group counseling. (Arch Intern Med. 1993;153:1881-1890)