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Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.

Publication ,  Journal Article
Shanahan, WR; Rose, JE; Glicklich, A; Stubbe, S; Sanchez-Kam, M
Published in: Nicotine Tob Res
August 1, 2017

INTRODUCTION: Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. METHODS: This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). RESULTS: Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. CONCLUSIONS: Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. IMPLICATIONS: This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological circuits involved with reward.

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Published In

Nicotine Tob Res

DOI

EISSN

1469-994X

Publication Date

August 1, 2017

Volume

19

Issue

8

Start / End Page

944 / 951

Location

England

Related Subject Headings

  • Weight Gain
  • Smoking Cessation
  • Smoking
  • Public Health
  • Nicotinic Agonists
  • Humans
  • Body Mass Index
  • Benzazepines
  • Adult
  • 4206 Public health
 

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Shanahan, W. R., Rose, J. E., Glicklich, A., Stubbe, S., & Sanchez-Kam, M. (2017). Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res, 19(8), 944–951. https://doi.org/10.1093/ntr/ntw301
Shanahan, William R., Jed E. Rose, Alan Glicklich, Scott Stubbe, and Matilde Sanchez-Kam. “Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.Nicotine Tob Res 19, no. 8 (August 1, 2017): 944–51. https://doi.org/10.1093/ntr/ntw301.
Shanahan WR, Rose JE, Glicklich A, Stubbe S, Sanchez-Kam M. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res. 2017 Aug 1;19(8):944–51.
Shanahan, William R., et al. “Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.Nicotine Tob Res, vol. 19, no. 8, Aug. 2017, pp. 944–51. Pubmed, doi:10.1093/ntr/ntw301.
Shanahan WR, Rose JE, Glicklich A, Stubbe S, Sanchez-Kam M. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res. 2017 Aug 1;19(8):944–951.
Journal cover image

Published In

Nicotine Tob Res

DOI

EISSN

1469-994X

Publication Date

August 1, 2017

Volume

19

Issue

8

Start / End Page

944 / 951

Location

England

Related Subject Headings

  • Weight Gain
  • Smoking Cessation
  • Smoking
  • Public Health
  • Nicotinic Agonists
  • Humans
  • Body Mass Index
  • Benzazepines
  • Adult
  • 4206 Public health