Smoking Cessation
Conditions
Brief summary
Many hospitals and outpatient clinics often refer people who smoke to quitlines and provide prescriptions for smoking cessation medications, but patients rarely fully engage in counseling or use their cessation medications. This is a single-arm, open-label pilot study to provide feasibility metrics for a text-based contingency management (CM) intervention to increase engagement in smoking cessation treatment. All participants (N=20) will be referred to a state quitline and will receive a prescription for medication plus 12 weeks of a text-based CM intervention to increase engagement in quitline calls and varenicline utilization. The engagement of participants in quitline counseling will be tracked for 6 weeks and medication utilization for 12 weeks post-enrollment. The investigators will use mixed-methods to collect implementation and acceptability data to inform changes to the text-based contingency management (CM) intervention.
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
BEHAVIORALCounsCM+MedCM (Health Rewards)
Small financial incentives for completing quitline calls (CounsCM) plus small financial incentives for taking varenicline (MedCM).
Sponsors
University of Kansas Medical Center
National Institute on Drug Abuse (NIDA)
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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) * Insurance coverage for varenicline * 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 |
|---|---|---|
| Proportion of quitline calls completed | Week 6 | Completion of the five quitline calls over 6 weeks of treatment 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 adherent to varenicline | Week 3 | Adherence biochemically verified using saliva samples, 1.0 ng/ml as the cutoff to distinguish between participants adherent and adherent |
| Proportion of self-reported varenicline pills taken | Week 3 | Self-reported use of varenicline from a timeline followback questionnaire assessing varenicline pills taken in each of the past 3 days |
| 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
Outcome results
None listed