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Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial
BACKGROUND: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-lik...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5943874/ https://www.ncbi.nlm.nih.gov/pubmed/29480848 http://dx.doi.org/10.1097/MD.0000000000009567 |
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author | Yammine, Luba Kosten, Thomas R. Cinciripini, Paul M. Green, Charles E. Meininger, Janet C. Minnix, Jennifer A. Newton, Thomas F. |
author_facet | Yammine, Luba Kosten, Thomas R. Cinciripini, Paul M. Green, Charles E. Meininger, Janet C. Minnix, Jennifer A. Newton, Thomas F. |
author_sort | Yammine, Luba |
collection | PubMed |
description | BACKGROUND: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking. AIMS: We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes. METHODS: We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to receive exenatide or placebo. All participants will receive transdermal nicotine replacement therapy (NRT) and behavioral counseling. Abstinence from smoking (verified via expired CO level of ≤5 ppm), craving (Questionnaire of Smoking Urges score), and withdrawal symptoms (Wisconsin Scale of Withdrawal Symptoms score) will be assessed weekly during 6 weeks of treatment and at 1 and 4 weeks posttreatment. Cue-induced craving for cigarettes will be assessed at baseline and at 3 weeks of treatment following virtual reality exposure. EXPECTED OUTCOMES: We hypothesize that exenatide will increase the number of participants able to achieve complete smoking abstinence above that achieved via standard NRT and that exenatide will reduce craving and withdrawal symptoms, as well as cue-induced craving for cigarettes. |
format | Online Article Text |
id | pubmed-5943874 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-59438742018-05-15 Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial Yammine, Luba Kosten, Thomas R. Cinciripini, Paul M. Green, Charles E. Meininger, Janet C. Minnix, Jennifer A. Newton, Thomas F. Medicine (Baltimore) Research Article BACKGROUND: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking. AIMS: We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes. METHODS: We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to receive exenatide or placebo. All participants will receive transdermal nicotine replacement therapy (NRT) and behavioral counseling. Abstinence from smoking (verified via expired CO level of ≤5 ppm), craving (Questionnaire of Smoking Urges score), and withdrawal symptoms (Wisconsin Scale of Withdrawal Symptoms score) will be assessed weekly during 6 weeks of treatment and at 1 and 4 weeks posttreatment. Cue-induced craving for cigarettes will be assessed at baseline and at 3 weeks of treatment following virtual reality exposure. EXPECTED OUTCOMES: We hypothesize that exenatide will increase the number of participants able to achieve complete smoking abstinence above that achieved via standard NRT and that exenatide will reduce craving and withdrawal symptoms, as well as cue-induced craving for cigarettes. Wolters Kluwer Health 2018-01-12 /pmc/articles/PMC5943874/ /pubmed/29480848 http://dx.doi.org/10.1097/MD.0000000000009567 Text en Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | Research Article Yammine, Luba Kosten, Thomas R. Cinciripini, Paul M. Green, Charles E. Meininger, Janet C. Minnix, Jennifer A. Newton, Thomas F. Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title | Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title_full | Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title_fullStr | Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title_full_unstemmed | Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title_short | Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
title_sort | exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5943874/ https://www.ncbi.nlm.nih.gov/pubmed/29480848 http://dx.doi.org/10.1097/MD.0000000000009567 |
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