Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial

Abstract

BackgroundVarenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility.ObjectiveThe primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation.MethodsThis is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales.ResultsThe project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway.ConclusionsTo the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials.Trial RegistrationClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ)Registered Report IdentifierRR1-10.2196/10826

Topiramate for smoking cessation: Systematic review and meta-analysis

“…The question is, however, what are the reliable measures for effectiveness of a treatment to enhance smoking cessation and for how long? An ongoing clinical trial is comparing varenicline and bupropion 25 . The primary outcome is smoking prevalence and continuous smoking abstinence, biochemically confirmed by salivary cotinine after 4, 8, 12, 26 and 52 weeks of starting a 12-week treatment.…”

“…The primary outcome is smoking prevalence and continuous smoking abstinence, biochemically confirmed by salivary cotinine after 4, 8, 12, 26 and 52 weeks of starting a 12-week treatment. A new meta-analysis examined efficacy of varenicline for smoking cessation in schizophrenia 25 . The outcome measures were: number of cigarettes and CO level over the treatment period up to 3 months.…”

Direct‐to‐participant investigational medicinal product supply in clinical trials in Europe: Exploring the experiences of sponsors, site staff and couriers

“…DtP supply has been used previously in a diverse set of clinical trials, [15][16][17][18][19][20][21][22][23] including trials to evaluate drugs for Alzheimer's disease 16 and antithrombotic therapies in patients with Covid-19 17 and to investigate drug adherence. 18 In line with the results of the current study, DtP IMP solutions are reported to be advantageous in clinical trials because of a "geographically dispersed rare population", as well as being more convenient for participants' daily lives, 16 enabling more pragmatic 19,20 and decentralized 21 trial approaches, limiting inperson interactions and thus allowing participants to quarantine during the Covid-19 pandemic, 17 facilitating the inclusion of a large number of physicians and patients, 22 decreasing the workload of the site study staff and minimizing potential interruptions in the treatment course. 23 Although DtP IMP supply has been reported throughout different phases of clinical development, 24 not all types of IMP may be suitable for DtP shipment, such as products with an unknown safety profile, complex route of administration or strict cold chain requirement.…”