Adaptive smoking cessation therapy using varenicline or nicotine patches 4 weeks prior to quitting plus bupropion if needed was more effective than standard smoking cessation treatment, according to clinical trial findings published in JAMA Network Open.
Adaptive pharmacotherapy, in which a medication regimen may be modified after initiation based on the patient’s response, is not common in smoking cessation. Researchers therefore assessed the effectiveness of smoking cessation using adaptive vs standard pharmacotherapy through a phase 2, double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT02501265). The primary outcome was biochemically verified 30-day continuous smoking abstinence at 12 weeks after the targeted quit date. Conducted at a Duke University Health System in Durham, North Carolina, from February 2018 to May 2020, the study’s enrollment period was cut short due to the COVID-19 pandemic.
The study included 188 adult patients (mean age, 49.1 years; 52% female; 52% White) who smoked daily for at least 1 year and were seeking smoking cessation. Patients already using smoking cessation products were excluded. All participants initially received a 20-minute counseling session with health education, motivational support, and instructions on medication use. Participants were stratified based on their choice of either varenicline (n=127) or nicotine patches (n=61) as their preferred method for smoking cessation treatment; within each treatment group, participants were randomly assigned 1:1 to adaptive treatment vs standard treatment.
Participants assigned to adaptive treatment received their chosen medication as precessation treatment over the 4 weeks prior to the targeted smoking quit date.
- Initially, those in the varenicline group received 1 mg twice daily; participants in the nicotine patch group started at a dose of 14 to 21 mg, depending on baseline cigarettes smoked per day.
- After 2 weeks, participants in both adapative treatment groups who did not decrease smoking by at least 50% were labeled as “nonresponders” and given an additional dose of 150 mg bupropion twice daily as part of their precessation regimen. Those who successfully decreased smoking by 50% received a bupropion placebo.
In the standard treatment groups, participants received a placebo pill or patch at 4 weeks before the targeted quit date. After 2 weeks, all participants in the standard treatment group received placebo bupropion. Actual treatment began 1 week prior to the target quit date for those in the varenicline group and on the quit date for those in the nicotine patch group.
For all groups, medications were continued for 12 weeks after the targeted quit date.
Only 137 of the study’s 188 participants attended the 12-week follow-up after the targeted quit date. The primary study endpoint of 30-day continuous smoking abstinence was observed in 24% (23/95) of participants in the adaptive treatment cohort vs 9% (8/93) of those in the standard treatment cohort (odds ratio [OR], 3.38; 95% CI, 1.43-7.99; P =.004).
Analysis by drug choice showed that among participants choosing varenicline, smoking abstinence was achieved by 28% of those in the adaptive treatment group vs 8% of those in the standard treatment group (OR, 4.54; 95% CI, 1.57-13.15). Among participants who selected nicotine patches, abstinence was achieved by 16% in the adaptive group vs 10% in the standard treatment group (OR, 1.73; 95% CI, 0.39-7.99).
Additionally, patients in both adaptive treatment groups had significantly lower mean reduction in measured carbon monoxide at 12 weeks after the targeted quit date, compared with patients in the standard treatment groups (adaptive vs standard treatment groups, 69.0% vs 38.6% reduction; P =.001).
Notably, sleep problems, including insomnia and vivid dreams, were significantly more common in the varenicline adaptive treatment group than its respective standard group (relative risk [RR], 1.74; 95% CI, 1.18-2.58; P =.03).
Study limitations include the exclusion of patients with symptomatic alcohol or substance use dependence, limited generalizability, and a small sample size due to the pandemic.
“[T]hese findings provide support for the use of precessation varenicline and precessation nicotine patches in an adaptive treatment regimen in which bupropion is provided to treatment nonresponders,” the study authors concluded.
This article originally appeared on Pulmonology Advisor