Initial Evaluation of Fenofibrate for Efficacy in Aiding Smoking Abstinence
© The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
INTRODUCTION: Primate and rodent models show that peroxisome proliferator-activated receptor-alpha (PPAR-α) ligands, including fibrate medications, reduce nicotine reinforcement, reward, and related effects. We tested fenofibrate, the most common U.S. Food and Drug Administration-approved fibrate for lipid control versus placebo for initial evidence of efficacy in smoking cessation using a validated cross-over procedure for early Phase 2 evaluations.
METHODS: Adult dependent smokers (N = 38) in this 4-week within-subjects study were those already intending to try to quit in the next 2 months. All smoked ad libitum during weeks 1 (baseline) and 3 (washout) and began fenofibrate (160 mg/d; dosing approved for lipid control) or placebo near the end of weeks 1 and 3. Following each 4-day dose run-up, they were then instructed to try to quit for 4 days (Tuesday-Friday) during weeks 2 and 4, with the order of medication conditions counter-balanced and administered double-blind. Abstinence was verified daily in each 4-day quit period by self-report of no smoking in the prior 24 hours and carbon monoxide < 5 ppm. Secondary measures of acute smoking reinforcement and cue reactivity prior to quitting, and smoking reduction when trying to quit, were also assessed.
RESULTS: No differences between fenofibrate versus placebo were found on days quit (means ± SEM of 1.8±0.3 vs. 1.9±0.3, respectively). Similarly, there were no differences in any of the secondary measures (all P > .20).
CONCLUSIONS: Although higher dosing or other proliferator-activated receptor-alpha agonists may show efficacy, this study indicates that fenofibrate does not aid ability to stop smoking during a brief practice quit period in dependent smokers high in current quit interest.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco - 18(2016), 1 vom: 21. Jan., Seite 74-8 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Perkins, Kenneth A [VerfasserIn] |
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| Links: |
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| Themen: |
7U1EE4V452 |
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| Anmerkungen: |
Date Completed 21.07.2016 Date Revised 11.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1093/ntr/ntv085 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM248266225 |
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| 245 | 1 | 0 | |a Initial Evaluation of Fenofibrate for Efficacy in Aiding Smoking Abstinence |
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| 520 | |a © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a INTRODUCTION: Primate and rodent models show that peroxisome proliferator-activated receptor-alpha (PPAR-α) ligands, including fibrate medications, reduce nicotine reinforcement, reward, and related effects. We tested fenofibrate, the most common U.S. Food and Drug Administration-approved fibrate for lipid control versus placebo for initial evidence of efficacy in smoking cessation using a validated cross-over procedure for early Phase 2 evaluations | ||
| 520 | |a METHODS: Adult dependent smokers (N = 38) in this 4-week within-subjects study were those already intending to try to quit in the next 2 months. All smoked ad libitum during weeks 1 (baseline) and 3 (washout) and began fenofibrate (160 mg/d; dosing approved for lipid control) or placebo near the end of weeks 1 and 3. Following each 4-day dose run-up, they were then instructed to try to quit for 4 days (Tuesday-Friday) during weeks 2 and 4, with the order of medication conditions counter-balanced and administered double-blind. Abstinence was verified daily in each 4-day quit period by self-report of no smoking in the prior 24 hours and carbon monoxide < 5 ppm. Secondary measures of acute smoking reinforcement and cue reactivity prior to quitting, and smoking reduction when trying to quit, were also assessed | ||
| 520 | |a RESULTS: No differences between fenofibrate versus placebo were found on days quit (means ± SEM of 1.8±0.3 vs. 1.9±0.3, respectively). Similarly, there were no differences in any of the secondary measures (all P > .20) | ||
| 520 | |a CONCLUSIONS: Although higher dosing or other proliferator-activated receptor-alpha agonists may show efficacy, this study indicates that fenofibrate does not aid ability to stop smoking during a brief practice quit period in dependent smokers high in current quit interest | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Michael, Valerie C |e verfasserin |4 aut | |
| 700 | 1 | |a Fromuth, Margaret |e verfasserin |4 aut | |
| 700 | 1 | |a Conklin, Cynthia A |e verfasserin |4 aut | |
| 700 | 1 | |a Chengappa, K N Roy |e verfasserin |4 aut | |
| 700 | 1 | |a Hope, Chris |e verfasserin |4 aut | |
| 700 | 1 | |a Lerman, Caryn |e verfasserin |4 aut | |
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