Smoking Cessation
Conditions
Brief summary
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.
Detailed description
Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM. The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.
Interventions
BEHAVIORALHealth Rewards
All 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).
BEHAVIORALControl
All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.
Sponsors
University of Kansas Medical Center
National Institute on Drug Abuse (NIDA)
University of Oklahoma
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoked in the past 30 days * Smoke at least 1 cigarette per day when they smoke * ≥ 18 years old * Kansas resident * Speak/read English * Access to a mobile phone * Mobile phone receives text messages * No varenicline contraindications (no acute renal impairment) * Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status) * Cognitively able to participate * Physically able to participate * Not pregnant/breastfeeding
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcomes | Week 3 to 12 | 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 | Week 12 | Completion of the five quitline calls according to Kansas quitline reports |
| Proportion of varenicline pills taken | Week 12 | Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with biochemically verified smoking abstinence | Week 12 | Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml |
| Proportion of patients with self-reported smoking abstinence | Week 12 | Past 7 days self-reported smoking abstinence |
Countries
United States
Contacts
CONTACTErica Cruvinel
CONTACTVinita Devarasetty, MPH
Outcome results
None listed