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Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia

BACKGROUND: HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smo...

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Autores principales: Tindle, Hilary A., Freiberg, Matthew S., Gnatienko, Natalia, Blokhina, Elena, Cheng, Debbie M., Yaroslavtseva, Tatiana, Bendiks, Sally, Winter, Michael, Krupitsky, Evgeny, Samet, Jeffrey H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7889999/
https://www.ncbi.nlm.nih.gov/pubmed/33659761
http://dx.doi.org/10.1016/j.conctc.2020.100625
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author Tindle, Hilary A.
Freiberg, Matthew S.
Gnatienko, Natalia
Blokhina, Elena
Cheng, Debbie M.
Yaroslavtseva, Tatiana
Bendiks, Sally
Winter, Michael
Krupitsky, Evgeny
Samet, Jeffrey H.
author_facet Tindle, Hilary A.
Freiberg, Matthew S.
Gnatienko, Natalia
Blokhina, Elena
Cheng, Debbie M.
Yaroslavtseva, Tatiana
Bendiks, Sally
Winter, Michael
Krupitsky, Evgeny
Samet, Jeffrey H.
author_sort Tindle, Hilary A.
collection PubMed
description BACKGROUND: HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation and may also reduce alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption has not been tested, nor has their comparative effectiveness been reported for smoking. OBJECTIVE: This paper describes the protocol of the Studying Partial agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), a four-arm parallel-group randomized controlled trial comparing effects of varenicline, cytisine, and nicotine replacement therapy (NRT). METHODS: The study is recruiting four hundred HIV-positive heavy drinking smokers interested in cutting down on alcohol and/or tobacco in St. Petersburg, Russia. Participants are randomly assigned to receive either active varenicline + NRT placebo, varenicline placebo + active NRT, active cytisine + NRT placebo, cytisine placebo + active NRT. All participants receive evidence-based counseling for alcohol and tobacco use, one active medication, and one placebo. Outcomes are: 1) % heavy drinking days in the past month (primary study outcome at three months) and alcohol craving; 2) cigarettes per day (primary smoking outcome at 3 months) and 7-day point prevalence abstinence and; 3) inflammation, CHD risk, and mortality risk. CONCLUSION: St PETER HIV addresses the paucity of randomized controlled trial data to guide treatment of alcohol consumption and smoking in HIV-positive heavy drinking smokers.
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spelling pubmed-78899992021-03-02 Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia Tindle, Hilary A. Freiberg, Matthew S. Gnatienko, Natalia Blokhina, Elena Cheng, Debbie M. Yaroslavtseva, Tatiana Bendiks, Sally Winter, Michael Krupitsky, Evgeny Samet, Jeffrey H. Contemp Clin Trials Commun Article BACKGROUND: HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation and may also reduce alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption has not been tested, nor has their comparative effectiveness been reported for smoking. OBJECTIVE: This paper describes the protocol of the Studying Partial agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), a four-arm parallel-group randomized controlled trial comparing effects of varenicline, cytisine, and nicotine replacement therapy (NRT). METHODS: The study is recruiting four hundred HIV-positive heavy drinking smokers interested in cutting down on alcohol and/or tobacco in St. Petersburg, Russia. Participants are randomly assigned to receive either active varenicline + NRT placebo, varenicline placebo + active NRT, active cytisine + NRT placebo, cytisine placebo + active NRT. All participants receive evidence-based counseling for alcohol and tobacco use, one active medication, and one placebo. Outcomes are: 1) % heavy drinking days in the past month (primary study outcome at three months) and alcohol craving; 2) cigarettes per day (primary smoking outcome at 3 months) and 7-day point prevalence abstinence and; 3) inflammation, CHD risk, and mortality risk. CONCLUSION: St PETER HIV addresses the paucity of randomized controlled trial data to guide treatment of alcohol consumption and smoking in HIV-positive heavy drinking smokers. Elsevier 2020-07-16 /pmc/articles/PMC7889999/ /pubmed/33659761 http://dx.doi.org/10.1016/j.conctc.2020.100625 Text en © 2020 Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Tindle, Hilary A.
Freiberg, Matthew S.
Gnatienko, Natalia
Blokhina, Elena
Cheng, Debbie M.
Yaroslavtseva, Tatiana
Bendiks, Sally
Winter, Michael
Krupitsky, Evgeny
Samet, Jeffrey H.
Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title_full Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title_fullStr Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title_full_unstemmed Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title_short Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia
title_sort design of a randomized controlled trial of smoking cessation medications for alcohol reduction among hiv-positive heavy drinkers and daily smokers in st. petersburg, russia
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7889999/
https://www.ncbi.nlm.nih.gov/pubmed/33659761
http://dx.doi.org/10.1016/j.conctc.2020.100625
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