Varenicline in addition to counseling was associated with improved rates of 7-day smoking abstinence among Black daily smokers. These findings, from a randomized, double-blind, placebo-controlled clinical trial, published in JAMA.
Black adults (N=500) who were daily cigarette smokers were recruited between 2015 and 2017 at the University of Kansas Medical Center. Participants were randomized in a 3:2 ratio to receive 12 weeks of 1 mg twice daily varenicline (n=300) or placebo (n=200) with 6 sessions of counseling and a culturally tailored educational guide. Varenicline was titrated up from 0.5 mg once daily over 7 days. Cigarette use was evaluated by saliva sample among individuals reporting abstinence and by urine sample among individuals reporting nicotine replacement use.
The varenicline and placebo cohorts comprised 52.0% and 53.0% women, aged mean 51.6 (SD, 11.9) and 52.4 (SD, 11.0) years, they smoked 12.9 (SD, 6.9) and 12.2 (SD, 6.2) cigarettes per day, 16.0% and 17.5% used other types of tobacco, 87.7% and 83.0% smoked menthol cigarettes, and 79.0% and 83.5% had attempted to quit in the past year, respectively.
Adherence to medication decreased from 81.5% at week 4 to 71.5% at week 12 (P <.001).
At week 26, 15.7% of varenicline recipients were biochemically verified to have 7-day abstinence compared with 6.5% of placebo recipients (odds ratio [OR], 2.7; 95% CI, 1.4-5.1; P =.002). Similar trends were observed at the end of medication treatment (OR, 3.0; 95% CI, 1.7-5.6; P <.001).
The effect was similar among individuals who smoked 1-10 cigarettes per day (OR, 3.0; 95% CI, 1.4-6.7; P =.004) as those who smoked 11 or more cigarettes per day (OR, 3.1; 95% CI, 1.1-8.6; P =.02) at baseline.
Any adverse event was reported by 94.2% of the varenicline and 90.8% of the placebo cohorts. The most common events were gas or flatulence (65.2% vs 66.3%), trouble sleeping (64.8% vs 59.7%), dry mouth (62.5% vs 65.8%), irritability (57.0% vs 56.6%), fatigue or loss of energy (55.6% vs 57.1%), nausea (55.6% vs 45.9%), and headache (53.6% vs 48.5%) among the active and control cohorts, respectively.
This study may have been underpowered to detect significant differences among subsets of individuals.
The study authors concluded, “Among African American daily smokers, varenicline added to counseling resulted in statistically significant improvement in the rates of 7-day point prevalence abstinence at week 26 compared to counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American daily smokers.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Cox LS, Nollen NL, Mayo MS, et al. Effect of varenicline added to counseling on smoking cessation among African American daily smokers: The Kick It at Swope IV randomized clinical trial. JAMA. 2022;327(22):2201-2209. doi:10.1001/jama.2022.8274