Smokers who followed an adaptive treatment regimen with drug patches had greater smoking abstinence after 12 weeks than did those who followed a standard regimen, based on data from 188 individuals.
Adaptive pharmacotherapy is a common strategy across many medical conditions, but its use in smoking cessation treatments involving skin patches has not been examined, wrote James M. Davis, MD, of Duke University, Durham, N.C., and colleagues.
In ain , the researchers reviewed data from 188 adults who sought smoking cessation treatment at a university health system between February 2018 and May 2020. The researchers planned to enroll 300 adults, but enrollment was truncated because of the COVID-19 pandemic.
Participants chose between varenicline or nicotine patches, and then were randomized to an adaptive or standard treatment regimen. All participants started their medication 4 weeks before their target quit smoking day.
A total of 127 participants chose varenicline, with 64 randomized to adaptive treatment and 63 randomized to standard treatment; 61 participants chose nicotine patches, with 31 randomized to adaptive treatment and 30 randomized to standard treatment. Overall, participants smoked a mean of 15.4 cigarettes per day at baseline. The mean age of the participants was 49.1 years; 54% were female, 52% were White, and 48% were Black. Baseline demographics were similar between the groups.
The primary outcome was 30-day continuous abstinence from smoking (biochemically verified) at 12 weeks after each participant’s target quit date.
After 2 weeks (2 weeks before the target quit smoking day), all participants were assessed for treatment response. Those in the adaptive group who were deemed responders, defined as a reduction in daily cigarettes of at least 50%, received placebo bupropion. Those in the adaptive group deemed nonresponders received 150 mg bupropion twice daily in addition to their patch regimen. The standard treatment group also received placebo bupropion.
At 12 weeks after the target quit day, 24% of the adaptive group demonstrated 30-day continuous smoking abstinence, compared with 9% of the standard group (odds ratio, 3.38; P = .004). Smoking abstinence was higher in the adaptive vs. placebo groups for those who used varenicline patches (28% vs. 8%; OR, 4.54) and for those who used nicotine patches (16% vs. 10%; OR, 1.73).
In addition, 7-day smoking abstinence measured at a 2-week postquit day visit was three times higher in the adaptive group compared with the standard treatment group (32% vs. 11%; OR, 3.30).
No incidents of death, life-threatening events, hospitalization, or persistent or significant disability or incapacity related to the study were reported; one death in the varenicline group was attributable to stage 4 cancer.
The findings were limited by several factors including the few or no participants of Alaska Native, American Indian, Hispanic, or Pacific Islander ethnicities, or those who were multiracial. The free medication and modest compensation for study visits further reduce generalizability, the researchers noted. Other limitations included the smaller-than-intended sample size and inability to assess individual components of adaptive treatment, they said.
However, the results support the value of adaptive treatment and suggest that adaptive treatment with precessation varenicline or nicotine patches followed by bupropion for nonresponders is more effective than standard treatment for smoking cessation.
The study was supported by the National Institute on Drug Abuse; the varenicline was provided by Pfizer. Dr. Davis had no financial conflicts to disclose.