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

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BACKGROUND: People with HIV (PWH) who smoke and drink are undertreated. Nicotinic partial agonists have potential to treat both.
METHODS: We conducted a randomized controlled trial among 400 heavy drinking (>5 heavy-drinking days [HDD] in past month) and daily-smoking PWH from 2017'2020 in St. Petersburg, Russia. All participants received brief alcohol/tobacco counseling, one medication, and one placebo (P), yielding 4 arms:
Arm 1: varenicline+P-NRT (nicotine replacement therapy);
Arm 2: P-varenicline+NRT;
Arm 3: cytisine+P-NRT; and
Arm 4: P-cytisine+NRT.
The 3 main pairwise comparisons were: Arms 1vs2; 3vs4 ; 1vs3. Three, 6, and 12 months outcomes were past-month HDD (primary outcome-3 months), cigarettes per day (CPD), biochemically-verified 7-day point prevalence abstinence from smoking. Alcohol abstinence at 3 months was defined as no self-reported alcohol consumption in past 30 days with biochemical confirmation (phosphatidyl ethanol level <8 ng/mL). We modeled HDD with negative binomial regression to estimate incidence rate ratios (IRR) and controlled for randomization stratification factors: past week alcohol consumption, daily cigarettes, and current ART use.
RESULTS: There were no major imbalances across randomized groups. Baseline characteristics were 66% male, mean age 39 years, mean CD4 count 391 cells/mm3, and 57% undetectable HIV viral load. All groups improved from baseline on primary and secondary outcomes at all time points (Table). There were no significant differences in our three main comparisons for number of HDD at 3 months: arms 1vs2 (IRR 0.91; 95%CI 0.51- 1.65, p=0.76), arms 3vs4 (IRR 0.68; 95%CI 0.37 -1.23, p= 0.60; arms 1vs3 IRR 1.12 (0.62, 2.03) p= 0.76. There were no serious medication-related adverse events.

CONCLUSIONS: Among PWH with heavy drinking, daily smoking, there were no differences in the number of HDDs between varenicline, cytisine and NRT. All groups reduced alcohol consumption and smoking through 12 months. These medications were well-tolerated. Future research should further investigate integrated alcohol/smoking care in PWH.