The study’s findings provide support for the use of precessation varenicline and nicotine patches in an adaptive treatment regimen where bupropion is provided to treat nonresponders.
Higher smoking abstinence rates were found among participants who received adaptive treatment than those who received nonadaptive treatment, according to results of a randomized trial published in JAMA Network Open.
Adaptive treatment, also known as adaptive pharmacotherapy, involves “assessing the patient’s response to an initial medication and then modifying the medication regimen based on the patient’s response.” It is a common medical practice, but it has not been widely used for smoking cessation. Despite this, the researchers noted that recent studies have found adaptive treatment to be effective for smoking cessation when using precessation nicotine patches, but it has not yet been fully assessed when using precessation varenicline.
Consequently, the researchers conducted a randomized clinical trial “to determine whether adaptive pharmacotherapy leads to higher smoking abstinence rates than standard pharmacotherapy in a clinical practice setting.” The study was conducted at Duke University Health System in Durham, North Carolina, from February 2018 to May 2020; it concluded early due to COVID-19.
The study population consisted of 188 individuals 18 years or older who were considered daily smokers for at least 1 year and were willing to attempt smoking cessation. The researchers had various exclusion criteria, including pregnancy and use of multiple tobacco products. Despite this, they noted their minimal use of exclusion criteria relative to other trials, as only 31% of their screened participants were excluded.
“This resulted in a study sample with rates of psychiatric comorbidity (30.8%) similar to that in US smokers (35%),” the authors wrote. “Of note, 72.8% of smoking cessation trials exclude some or all potential participants due to mental illness. The study sample also had a higher portion of Black or African American participants (43%) than is found in the general US population (13.6%) and in the US population of smokers (20.4%).”
The researchers allowed participants to choose varenicline or nicotine patches before randomly assigning them either adaptive or standard treatment. Of the participants, 127 chose to use varenicline; 64 were randomized to adaptive treatment, and the other 63 received standard treatment. On the other hand, 61 chose to use nicotine patches, 31 of which were randomized to adaptive treatment, the other 30 receiving standard treatment.
Participants began their chosen medication (adaptive) or placebo (standard) 4 weeks before their target quit day and were assessed for treatment response 2 weeks later. At check-ups, adaptive participants who did not decrease their number of daily cigarettes by at least 50% were considered nonresponders and received bupropion along with their chosen medication. On the other hand, those in the adaptive treatment group who decreased their daily cigarette amount by at least 50% were considered responders, and they, along with all participants in the standard treatment group, received placebo bupropion along with their chosen medication.
Twelve weeks after the target quit day, the researchers observed biochemically verified 30-day continuous smoking abstinence in 23 of 95 participants (24%) in the adaptive treatment group and 8 of 93 (9%) in the standard treatment group (odds ratio [OR], 3.38; 95% CI, 1.43-7.99; P = .004). Of the participants who used varenicline and maintained 30-day continuous abstinence, 18 (28%) were in the adaptive treatment group and 5 (8%) were in the standard treatment group (OR, 4.54; 95% CI, 1.57-13.15). On the other hand, of the participants who used nicotine patches and maintained 30-day continuous abstinence, 5 (16%) were in the adaptive treatment group and 3 (10%) were in the standard treatment group (OR, 1.73; 95% CI, 0.38-7.99).
These findings show that adaptive treatment was effective for smoking cessation as the researchers found higher smoking abstinence rates among participants randomized to adaptive pharmacotherapy. Consequently, the study provided support for the use of precessation varenicline and nicotine patches in an adaptive treatment regimen where bupropion is provided to treat nonresponders.
The researchers also acknowledged their study’s limitations, one being that it was designed to compare adaptive treatment with standard treatment overall, resulting in individual components being overlooked. Also, the study population consisted of few or no Alaska Native, Asian, American Indian, Pacific Islander, Hispanic or Latinx, or multiracial people, which limited the generalizability of the study’s findings to these groups. Although these limitations decreased the study’s strength, the researchers noted that they did not negate its findings.
“This study’s design provides greater generalizability to clinical populations,” the authors concluded. “Our findings support an evolving body of literature on adaptive treatment.”
Davis JM, Masclans L, Rose JE. Adaptive smoking cessation using precessation varenicline or nicotine patch: a randomized clinical trial. JAMA Netw Open. 2023;6(9):e2332214. doi:10.1001/jamanetworkopen.2023.32214