A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation
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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). By week 7, subjects in the placebo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group (P<0.05 for both comparisons). A total of 311 subjects (34.8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and headache. CONCLUSIONS: Treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant.
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Varenicline is a potent α4 β2 partial agonist that provides tobacco withdrawal relief by its agonist action and blocks the reinforcing effects of nicotine by its antagonist action.
“This drug is varenicline, a potent α4 β2 partial agonist, which provides tobacco withdrawal relief by its agonist action and blocks the reinforcing effects of nicotine by its antagonist action (103, 104).”
From Tobacco addiction (2008) · cites this paper as [104]
Of three trials comparing varenicline to bupropion, two had significant effects on long-term abstinence and the pooled OR showed a significant effect for varenicline (OR 1.7, 95% CI 1.3 to 2.2).
“Of the three trials comparing varenicline to bupropion, two had significant effects on long term abstinence and the pooled OR showed a significant effect for varenicline (OR 1.7, 95% CI 1.3, 2.2).”
From Tobacco addiction (2008) · cites this paper as [104]
The major side effect for varenicline was nausea; about 30% of participants experienced this symptom.
“The major side effect for varenicline was nausea; about 30% of participants experienced this symptom.”
From Tobacco addiction (2008) · cites this paper as [104]
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- Authors
- Jorenby, D. E., Leischow, S. J., Nides, M. A., Rennard, S. I., Johnston, J. A., Hughes, A. R., Smith, S. S., Muramoto, M. L., Daughton, D. M., Doan, K., Fiore, M. C., & Baker, T. B.
- Affiliations
- University of Wisconsin–Madison (US)
- University of Arizona (US)
- Los Angeles Clinical Trials (US)
- University of Nebraska Medical Center (US)
- Sigma Xi (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1999-03-04
- Volume
- 340
- Issue
- 9
- Pages
- 685-691
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2312609348
- Cited by
- 1,585
- References
- 23
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 9 · 2023: 18 · 2022: 20 · 2021: 17 · 2020: 24 · 2019: 20 · 2018: 22 · 2017: 26 · 2016: 36 · 2015: 39 · 2014: 40 · 2013: 43 · 2012: 41
- FWCI
- 65.31
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Keywords
- smoking cessation, bupropion sustained release, nicotine patch, nicotine replacement therapy, combination therapy, abstinence rates, weight gain, adverse events, insomnia, headache, antidepressants, nicotine dependence, long-term follow-up, treatment discontinuation, nicotine withdrawal symptoms
- MeSH terms
- Administration, Cutaneous, Adult, Delayed-Action Preparations, Drug Therapy, Combination, Female, Humans, Male, Nicotine, Substance Withdrawal Syndrome, Weight Gain, Smoking Cessation, Bupropion, Antidepressive Agents, Second-Generation
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