The combination of varenicline and naltrexone was superior to placebo, and at times superior to monotherapy, in attenuating cigarette craving, cigarette and alcohol subjective “high,” and reducing ad libitum consumption of cigarettes and alcohol. Toward improving treatments for heavy-drinking smokers, our laboratory previously conducted an experimental medicine study ( 23) in which we compared the effects of varenicline only, naltrexone only, the combination of varenicline and naltrexone, and matched placebo. While varenicline and naltrexone have FDA approval for nicotine and alcohol use disorders, respectively, there is evidence that their clinical benefit may extend across the two disorders. ![]() Food and Drug Administration (FDA) for the treatment of alcohol use disorder (AUD) ( 19, 20), and it has been shown to increase smoking cessation rates, particularly among heavy-drinking smokers ( 21, 22). Naltrexone, an opioid receptor antagonist, is approved by the U.S. ![]() Studies have shown that in addition to its smoking cessation benefits, varenicline may also reduce alcohol consumption ( 16 – 18). Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, is the most effective pharmacotherapy for smoking cessation ( 14), with an estimated 1 in 8 patients being abstinent from smoking at 1-year follow-up ( 15). While heavy-drinking smokers constitute a sizable subgroup with a higher risk of negative consequences and failed quit attempts, there are no available pharmacological treatments tailored to heavy-drinking smokers ( 12, 13). It is estimated that smokers are up to four times more likely to experience a smoking lapse during drinking episodes in the course of smoking cessation treatment ( 7). Notably, both smoking ( 9) and heavy drinking ( 10, 11) have been associated ith worse outcomes for COVID-19, highlighting the importance of treating both conditions. Heavy-drinking smokers experience more negative health consequences, such as greater risk for various cancers ( 5), as well as a lower likelihood of successful smoking cessation ( 4, 6 – 8). Alcohol use and smoking have high rates of co-use, such that approximately 20%−25% of current smokers are considered heavy drinkers ( 3, 4). ![]() Cigarette smoking ( 1) and heavy alcohol use ( 2) are leading causes of morbidity and mortality in the United States and worldwide.
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