No published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.
Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents)
Reports daily smoking ≥5 cigarettes per day
Provides a breath CO sample ≥6ppm to verify current smoking
Willing to schedule a smoking cessation attempt within the next 1-2 weeks
Does not own a smartphone that is compatible with the study app
Using an FDA-approved smoking cessation medication within the past 30 days
Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days
History of seizures (varenicline contraindication)
Factorial
Varenicline (VAR)
Drug13 weeks of varenicline
Nicotine lozenge (NRT)
Drug12 weeks of nicotine lozenges
Smartphone intervention with adherence components (COMBO-A)
BehavioralSmartphone-based smoking cessation intervention with adherence components
Smartphone intervention without adherence components (COMBO-B)
BehavioralSmartphone-based smoking cessation intervention without adherence components
Telephone Counseling
BehavioralUp to 6 telephone counseling sessions with a tobacco treatment specialist
Smoking Abstinence (26 weeks post-quit)
Self-reported smoking abstinence over the past 7 days with breath CO≤6 ppm
Medication Adherence (weekly)
Adapted 7-item version of the Adherence to Refills and Medications Scale (ARMS). Separate scales will be administered to assess past-week varenicline and nicotine lozenge adherence. Scores may range from 7-28, with lower scores indicating better adherence.
Medication Adherence (daily)
Smartphone daily diary assessments of previous day varenicline and lozenge adherence.
Smoking Abstinence (12 weeks post-quit)
Self-reported smoking abstinence over the past 7 days with breath CO≤6 ppm
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University of Oklahoma
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Brown University
Collaborator
Thomas Jefferson University
Collaborator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborator
