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

Contemporary Clinical Trials Communications

Elena Blokhina¹  Debbie M. Cheng²  Matthew S. Freiberg³  Sally Bendiks⁴  Natalia Gnatienko⁵  Jeffrey H. Samet⁶  Michael Winter⁷  Evgeny Krupitsky⁸  Hilary A. Tindle⁹  Tatiana Yaroslavtseva^1,10 

[1] Corresponding author. ViTAL, the Vanderbilt Center for Tobacco, Addiction and Lifestyle, Division of General Internal Medicine &Public Health and Vanderbilt Ingram Cancer Center (VICC), 2525 West End Ave, Suite 450, Nashville, TN 37203, , United States.;Public Health and Vanderbilt Ingram Cancer Center, 2525 West End, Suite 450, Nashville, TN, 37203, United States;Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Vanderbilt University Medical Center, Division of Cardiovascular Medicine, 2525 West End, Suite 300-A, Nashville, TN, 37203, United States;Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center (GRECC), Nashville, TN, United States;Department of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, 3rd Floor, Boston, MA, 02118, United States;Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, United States;Pavlov University, Lev Tolstoy St. 6-8, St. Petersburg, 197022, Russian Federation;;Vanderbilt Center for Tobacco, Addiction and Lifestyle (ViTAL), Vanderbilt University Medical Center, Division of General Internal Medicine &Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center (GRECC), Nashville, TN, United States;

关键词: Russia;    HIV;    Alcohol use;    Smoking;    Varenicline;    Cytisine;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown