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This research was the result of the first study assessing adaptive smoking cessation treatment within a clinical population using very few criteria for exclusion.
The practice of adaptive pharmacotherapy can be effective for enacting smoking cessation treatment within a clinical practice setting, according to recent findings.1
This new research resulted from a study comparing adaptive versus standard pharmacotherapy and determining which leads to higher rates of smoking abstinence in such a setting. Prior research had shown that adaptive treatment practices involving a potential medication adjustment based on response had been widely-used but not for smoking specifically.
That said, related studies had shown some success such as a trial from 2013 that found nonresponders to pre-cessation nicotine patches could be helped through the use of twice-per-day bupropion 150 mg, leading to much higher 6-month abstinence versus those using nicotine patch by itself.2
This latest study on adaptive pharmacotherapy as a practice for smoking cessation was led by James M. Davis, MD, from the Duke Center for Smoking Cessation at Duke University’s School of Medicine in Durham, North Carolina.
“To our knowledge, there have been no studies assessing adaptive treatment in clinical populations with minimal exclusion criteria, nor studies assessing adaptive treatment for smokers using pre-cessation varenicline,” Davis and colleagues wrote.
The investigators used a double-blinded, stratified, and placebo-controlled randomized clinical trial, seeking to assess the effectiveness of adaptive treatment in comparison to the standard treatment for cessation of smoking. The team’s work took place in the Duke University health system and went from February 2018 to May 2020.
The research was prematurely halted as a result of the unexpected effects of the COVID-19 pandemic. After this pause, the team’s analysis of data was carried out through the use of an intent-to-treat approach from May 2021 to February 2022.
The investigators granted the study’s participants the ability to select between receiving varenicline or nicotine patches as their first choices for treatment, after which they were then randomly placed into either the adaptive or nonadaptive (standard) treatment arm. The individuals began their choice of medication (adaptive) or placebo (standard) around 4 weeks prior to their determined ‘quit day.’
Individuals involved in the study, for 2 weeks, were given an assessment to examine their response to treatment. Specifically, adaptive individuals who were shown not to exhibit a reduction of 50% minimum in their daily use of cigarettes were labeled as ‘nonresponders’ and were given bupropion supplementation in addition to their initial medication.
The responders placed in the adaptive treatment arm and those in the standard treatment arm were given placebo bupropion. For those in the standard group, the administration of varenicline or nicotine patches took place either a single week prior to or on the target quit day, respectively.
Notably, the investigators gave all of the participants brief behavioral support as an element of the overall protocol for treatment. The team’s primary endpoint was determined to be the biochemically verified 30-day continuous abstinence from smoking, and this was determined 12 weeks following the target quit date, with further information collection encompassing demographics, history of smoking, and repeated assessments of behavior related to smoking.
Overall, among the initially-planned 300 study participants, 188 ended up being recruited in the research, and they had an average age of 49.1 years. Furthermore, 54% were reported tyo be female prior to the trial being halted due to the COVID-19 pandemic.
Among these individuals, 127 were shown to have opted for varenicline, with 64 placed in the adaptive treatment arm and 63 in the standard treatment arm. The investigators added that 61 individuals decided to receive nicotine patches, with 31 being from the adaptive arm and 30 in the standard arm.
In the beginning, the study participants had smoked an average of 15.4 cigarettes per day. Following 12 weeks from the target quit date, the investigators determined that the adaptive treatment arm showed a substantially higher biochemically verified 30-day continuous smoking abstinence rate as opposed to those in the standard treatment arm, especially in the varenicline subgroup.
However, the research team noted that those in the varenicline adaptive treatment arm were found to have experienced more sleep-related issues versus those in the varenicline standard treatment arm.
The investigators also noted that while the rates of abstinence of its participants were lower than their reference studies, the numbers were still sizable enough to be clinically meaningful.
“Specifically, these findings provide support for the use of pre-cessation varenicline and pre-cessation nicotine patches in an adaptive treatment regimen in which bupropion is provided to treatment nonresponders,” they wrote.