The smoking cessation aid varenicline tartrate is effective for reducing heavy drinking in men with alcohol use disorder and comorbid cigarette smoking, according to findings published Dec. 20, 2017. The drug also increased smoking abstinence in participants overall, reported Stephanie S. O’Malley, PhD, of the department of psychiatry at Yale University, New Haven, Conn., and her coauthors.

In a phase 2, randomized, double-blind study of 131 patients, varenicline treatment resulted in a significant decrease in the percentage of heavy drinking days (PHDD) at 9-16 weeks in men, compared with placebo (P = .09). Additionally, 29% of men taking varenicline had no heavy drinking days (NHDD) during the trial period. NHDD was defined as never drinking four or more drinks per day for women or five or more drinks per day for men, Dr. O’Malley and her colleagues wrote in JAMA Psychiatry.

Women had a smaller decrease in PHDD (P = .15), and 5% had NHDD, compared with 25% of the women on placebo.

The trial was conducted between September 2012 and August 2015 at research facilities affiliated with Columbia University in New York and with Yale. The study group was made up of 92 men and 39 women aged 18-70 years who met DSM-IV-TR criteria for alcohol dependence. Most of the respondents (52.7%) identified themselves as black. They reported heavy drinking at least twice per week for the preceding 90 days, having seven or fewer consecutive days of alcohol abstinence, and smoking at least twice per week, the investigators reported.

Among participants receiving varenicline, 13% achieved prolonged smoking abstinence at 13-16 weeks, the authors reported, whereas none of the participants on placebo quit smoking (P = .003).

The sex differences in the trial may be attributed to differences in baseline characteristics, such as greater alcohol dependence and lower nicotine dependence, Dr. O’Malley and her colleagues said.

Additionally, women were more likely to reduce or discontinue varenicline dose. “From a methodological perspective, we permitted dose reductions to minimize adherence problems because lower varenicline doses are effective for smoking cessation,” they said.

The clinical implications of the findings are important, Dr. O’Malley and her colleagues said. “Individuals treated for alcoholism are more likely to die of smoking than from alcohol-related causes,” they wrote, and “most smokers do not receive smoking-cessation assistance, yet heavy-drinking smokers see these behaviors as highly associated.”

Lastly, the trial was limited by the small sample size of women.

“Future studies should evaluate the effectiveness and safety of varenicline in women and men separately in larger samples to establish whether the observed effects are of clinical significance,” the authors concluded.

The study was funded by grants from the National Institutes of Health and from Connecticut’s Department of Mental Health and Addiction Services. Pfizer, the manufacturer of varenicline under the name Chantix, provided varenicline and placebo pills.

The authors disclosed relationships with several companies, including Pfizer.

SOURCE: O’Malley SS et al. JAMA Psychiatry. 2017 Dec 20. doi: 10.1001/jamapsychiatry.2017.3544.


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