Changing Tack From Nicotine Patch Fails in Black Smokers

In Black adults looking to stop smoking, medication switches early on during a failed quit attempt didn’t prove significantly better than sticking with the nicotine patch, an open-label randomized trial showed.

The single-center study, which assigned nearly 400 Black smokers to counseling plus either adapted therapy (ADT) or usual care with a nicotine patch alone, showed no significant benefit in quit rates at 12 weeks with the multiple pharmacotherapy approach (OR 1.58, 95% CI 0.89-2.80, P=0.12), reported Nicole Nollen, PhD, of the University of Kansas School of Medicine in Kansas City, and colleagues in JAMA Network Open.

At that point, 17% of patients in the ADT group — where patients started on the nicotine patch but switched therapy if they weren’t responding, first to varenicline (Chantix) and then to bupropion (Zyban) plus a nicotine patch — achieved the primary outcome of verified abstinence for 7 days versus 12% of those in the usual care group.

And quit rates at the end of the 18-week treatment course and at end of study were also similar between groups.

“That UC [usual care] worked as well as ADT is encouraging given that UC requires fewer components, is less costly, and is easier to manage within the healthcare system,” the researchers wrote. “Our findings add to a growing body of literature suggesting that multicomponent interventions increase participant burden and decrease adherence without conferring additional treatment benefit.”

Of the 135 individuals in the ADT group who ultimately switched from the nicotine patch to one or both of the other approaches, only 11 patients (8.1%) abstained from smoking at 12 weeks.

“Early abstinence is an important but overlooked target for intervention,” wrote Nollen and co-authors. “More than two-thirds of individuals who smoke and do not achieve abstinence within 4 weeks of initiating pharmacotherapy do not achieve abstinence at later time points.”

In the current study, patients in either group who responded to treatment at week 2 were over four times as likely to be abstinent after 12 weeks compared to those who didn’t respond (28.7% vs 7.8%).

“The current standard care for tobacco treatment recommends continuing an individual on pharmacotherapy for 8 to 12 weeks even if they continue to smoke, which is in direct contrast to treatment of other chronic diseases (e.g., hypertension, diabetes) where altering medications to achieve desired outcomes are commonplace,” they added.

According to Nollen and colleagues, prior ADT studies were limited for various reasons, including that they tested only one adapted approach or switched therapies at a more distal point to the failed quit attempt.

And past studies were conducted largely in white smokers, leaving evidence gaps. While Black adults have similar smoking rates as other racial or ethnic groups, they bear a disproportionate amount of tobacco-related diseases, the researchers noted.

Nollen and colleagues enrolled 392 non-Hispanic African-American adults looking to quit smoking in the metropolitan Kansas City area, with the study conducted from May 2019 to January 2022 at Swope Health, a federally qualified health center in Kansas City. At enrollment, participants were required to have an exhaled carbon monoxide (CO) level of 5 ppm or above.

Participants had an average age of 53 years, 57% were women, and a little less than half were at or below the federal poverty level. They smoked a mean of 13 cigarettes per day, had smoked for 34 years on average, and most smoked menthols (88%).

All participants received seven smoking cessation counseling sessions with an accredited Tobacco Treatment Specialist and were randomized 1:1 to 18 weeks of either ADT or usual care with the nicotine patch alone (24-hour 21 mg). Patients in the ADT group were first given a nicotine patch (same dose) and switched to varenicline if they hadn’t responded (CO status of ≤5 ppm) at 2-week follow-up. At 6 weeks, non-responders to varenicline were switched to bupropion plus the nicotine patch.

Participants were eligible for $350 in total compensation if they finished the study activities, with payment based on visit attendance, and overall 324 completed all 26 weeks of the study. As the study was conducted on an intent-to-treat basis, missing participants were counted as smokers.

The primary endpoint was anabasine- and anatabine-verified point prevalence smoking abstinence (≤2 ng/mL⁵⁰) at week 12. For the secondary endpoints, verified abstinence rates were similar between the ADT and usual care groups, respectively, both at end of treatment (18 weeks) and end of study (26 weeks):

• 18 weeks: 16.3% vs 15.8% (P=0.89)
• 26 weeks: 12.2% vs 13.3% (P=0.76)

Adherence to the counseling sessions was similar between arms (mean 5.4 in the ADT group and 5.6 in the usual care group), as was adherence to treatment (60% and 56%, respectively).

Study limitations included the fact that usual care was considered to be “more intense” than typical interventions in primary care, and that the 3 weeks of full doses of varenicline may have been insufficient to produce the drug’s full effect, the researchers acknowledged.