About this trial
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Smoked in the past 30 days
Smoke at least 1 cigarette per day when they smoke
≥ 18 years old
Kansas resident
Disqualifiers
Medically ineligible for varenicline
Patient on smoking cessation medication within 2 weeks of admission date
Patient already talked to quitline in the past 2 weeks.
Patients participating in other quit smoking program or research study
Trial design
Parallel
Treatments tested in this trial
Health Rewards
BehavioralAll participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM).
Control
BehavioralAll participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility outcomes
Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.
Proportion of quitline calls completed
Completion of the five quitline calls according to Kansas quitline reports
Proportion of varenicline pills taken
Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting
Secondary outcomes
Proportion of patients with biochemically verified smoking abstinence
Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml
Proportion of patients with self-reported smoking abstinence
Past 7 days self-reported smoking abstinence
Sponsors and contacts
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University of Kansas Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Oklahoma
Collaborator
University of Toronto
Collaborator
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