Nicotine vs Placebo Gum in General Medical Practice

Hughes, John R.; Gust, Steven W.; Keenan, Robert M.; Fenwick, James W.; Healey, Margaret

doi:10.1001/jama.1989.03420090064032

Cited by 104 publications

(4 citation statements)

References 24 publications

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“…Only four nicotine patch studies have examined whether blindness failure moderated medication efficacy. Three studies found no evidence of moderation (Hall et al, 1987; Hughes et al, 1989; Tonnesen et al, 1991). In the fourth study, which investigated whether the nicotine patch helped smokers to reduce their smoking, Dar et al (2005) found a significantly greater reduction in smoking among participants in both the active and placebo conditions who guessed that they received active medication.…”

Section: Discussionmentioning

confidence: 94%

Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: Results from a randomized, double-blind, placebo-controlled study

Kalman¹,

Herz²,

Monti³

et al. 2011

Drug and Alcohol Dependence

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Aims The primary aim of this study was to compare the efficacy of smoking cessation treatment using a combination of nicotine patch and bupropion vs. nicotine patch and placebo bupropion. A secondary aim was to investigate whether the efficacy of bupropion is moderated by belief about whether one is receiving active or placebo medication. Methods Participants were recruited from a residential substance abuse treatment program and the community. We randomly assigned 148 smokers with between two and twelve months of alcohol abstinence to nicotine patch plus bupropion or nicotine patch plus placebo. All participants also received seven counseling sessions. Results At follow up, differences between medication conditions were not significant. Seven-day point prevalence quit rates in the patch plus bupropion vs. patch plus placebo conditions at week 24 were 6% and 11%, respectively. Differences between groups on prolonged abstinence and time to first smoking lapse were also not significant. However, among participants who received bupropion, those who accurately “guessed” that they were receiving bupropion were more likely to remain abstinent than those who incorrectly believed they were receiving placebo. Conclusions Findings do not support combining nicotine patch and bupropion for smoking cessation in this population. However, findings support previous studies suggesting the importance of assessing the blind in smoking cessation studies and its possible moderating effect on medication efficacy. Future directions for enhancing smoking cessation outcome in these smokers include investigations of intensive behavioral and pharmacological interventions, including studies of potential interactions between individual genetic differences and medication efficacy.

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Section: Discussionmentioning

confidence: 94%

Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: Results from a randomized, double-blind, placebo-controlled study

Kalman¹,

Herz²,

Monti³

et al. 2011

Drug and Alcohol Dependence

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show abstract

“…Under these assumptions 300 smokers were to be randomly assigned to each group. The 6-month period was chosen because evidence suggests that cessation rates at 6 and 12 months do not differ substantially [24][25][26][27][28][29][30][31][32] and in a lower socioeconomic status population, it may have been difficult to follow up all participants for a year.…”

Section: Discussionmentioning

confidence: 99%

Sustained-Release Bupropion for Smoking Cessation in African Americans

Ahluwalia

Harris²,

Catley³

et al. 2002

JAMA

229

191

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Context African Americans disproportionately experience greater smoking attributable morbidity and mortality. Few clinical trials for smoking cessation in African Americans have been conducted, despite a different profile of both smoking and quitting patterns.Objective To compare a sustained-release form of bupropion hydrochloride (bupropion SR) with placebo for smoking cessation among African Americans.Design, Setting, and Participants Randomized, double-blind, placebocontrolled trial conducted from February 11, 1999, to December 8, 2000, of 600 African American adults treated at a community-based health care center. Volunteers, who smoked 10 or more cigarettes per day were recruited by targeted media and health care professionals.Intervention Participants were randomly assigned to receive 150 mg of bupropion SR (n=300) or placebo (n=300) twice daily for 7 weeks. Brief motivational counseling was provided in-person at baseline, quit day, weeks 1 and 3, end of treatment (week 6), and by telephone at day 3 and weeks 5 and 7.Main Outcome Measures Biochemically confirmed 7-day point prevalence abstinence at weeks 6 and 26 following quit day. ResultsUsing intention-to-treat procedures, confirmed abstinence rates at the end of 7 weeks of treatment were 36.0% in the bupropion SR group and 19.0% in the placebo group (17.0 percentage point difference; 95% confidence interval, 9.7-24.4; PϽ.001). At 26 weeks the quit rates were 21.0% in the treatment and 13.7% in the placebo groups (7.3 percentage point difference; 95% confidence interval, 1.0-13.7; P=.02). Those taking bupropion SR experienced a greater mean reduction in depression symptoms at week 6 (2.96 [9.45] vs 1.13 [8.84]) than those taking placebo, and after controlling for continuous abstinence, those taking bupropion SR also gained less weight than those taking placebo.Conclusions Bupropion SR was effective for smoking cessation among African Americans and may be useful in reducing the health disparities associated with smoking.

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“…Over time, trials moved into more typical treatment settings (e.g. general hospitals [27], hospital outpatient smoking cessation clinics [28], primary care [29] and even over-thecounter settings [30,31]) and some of these studies obtained less impressive results. For example, the British Thoracic Society study randomised over 1500 patients to nicotine or placebo gum with or without an informational booklet and found that less than 10% quit overall; those receiving nicotine gum did not have better cessation outcomes than those receiving placebo [32].…”

Section: Concerns About 'Real World' Effectiveness Of Nrtmentioning

confidence: 99%

Developments in pharmacotherapy for tobacco dependence: past, present and future

Foulds

Steinberg

Williams

et al. 2006

Drug and Alcohol Review

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In the mid-1970s there were no effective pharmacological treatments for tobacco dependence. The invention of nicotine gum was a major treatment advance and also greatly helped our understanding of the nature of tobacco dependence. There are now eight effective pharmacotherapies (nicotine gum, patch, nasal spray, inhaler, lozenge/tablet, bupropion, nortriptyline and clonidine) available to aid smoking cessation. Other non-nicotine agents that show promise are under investigation, including glucose, rimonabant, selegiline and varenicline. Greater knowledge of the mechanisms of action of the effective non-nicotine agents should lead to better understanding of the nature of tobacco dependence. Future research into optimal treatments should examine long-term combination pharmacotherapy combined with improved psychosocial support that is partly designed to enhance medication compliance. In addition, there is a need for studies designed to evaluate the efficacy of pharmacotherapies in populations such as youth, pregnant smokers and smokers with co-occurring mental health problems.

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Nicotine vs Placebo Gum in General Medical Practice

Cited by 104 publications

References 24 publications

Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: Results from a randomized, double-blind, placebo-controlled study

Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: Results from a randomized, double-blind, placebo-controlled study

Sustained-Release Bupropion for Smoking Cessation in African Americans

Developments in pharmacotherapy for tobacco dependence: past, present and future

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