 |
“Men appeared to derive benefit from varenicline, compared with placebo, on measures of heavy drinking, whereas women did better taking placebo,” wrote lead author Stephanie S. O’Malley, Ph.D., director of the Division of Substance Abuse Research in Psychiatry at Yale School of Medicine.
Researchers conducted the phase 2, randomized, double-blind, placebo-controlled trial at two outpatient clinics (New York City and New Haven, Conn.) from September 19, 2012, to August 31, 2015. The researchers recruited men and women aged 18 to 70 who were seeking treatment for AUD. Individuals who met the criteria for alcohol dependence (according to the DSM-IV-TR), reported heavy drinking (≥5 standard alcoholic drinks for men and ≥4 drinks for women) two or more times a week and cigarette smoking two or more times per week were included in the trial.
O’Malley and colleagues randomly assigned 131 participants to receive either 2 mg of varenicline or placebo daily for 16 weeks. Medication was titrated in the following standard doses: 0.5 mg once daily for three days, 0.5 mg twice daily for four days, and 1 mg twice daily for the remainder of the 16-week treatment. Daily medication adherence was monitored through a combination of pill counts returned from blister packs and self-reported compliance.
Over the course of the trial, participants attended 12 medical management sessions during which they met with a medical professional to discuss the tolerability of the assigned medication, medication adherence, and the importance of drinking goals as well as the development and implementation of strategies for changing drinking behaviors. The participants were also asked about their drinking and smoking behavior, adverse effects of the medication, changes in mood, and more.
The mean change from baseline in the percentage of heavy drinking days in the overall sample by the end of the study was not different between the placebo and medication groups, but varenicline appeared to have different effects on drinking in men and women. Compared with placebo, varenicline resulted in a greater decrease in percentage of heavy drinking days in men and a smaller decrease in percentage of heavy drinking days in women. Even though the subjects were not seeking or provided smoking-cessation counseling, varenicline resulted in significantly higher rates of smoking abstinence compared with placebo (13% vs 0%) at the end of treatment.
“This study adds to the growing body of evidence suggesting varenicline to be well tolerated in those with active substance use disorders,” wrote A. Eden Evans, M.D., Ph.D., and John F. Kelly, Ph.D., both of the Center for Addiction Medicine at Massachusetts General Hospital and Harvard Medical School., in an accompanying editorial in JAMA Psychiatry. “These findings highlight the importance of the National Institutes of Health’s emphasis on systematically evaluating sex or gender in treatment effects and add to the converging evidence of the need for more specific and targeted treatments for women and men.”
For related information, see the Psychiatric News article “APA Releases Practice Guideline for AUD Pharmacotherapy.”
(Image: iStock/Bunyos)
