MedPath

Contingency Management to Promote Smoking Cessation

Not Applicable
Not yet recruiting
Conditions
Smoking Cessation
Interventions
Behavioral: CounsCM+MedCM (Health Rewards)
Registration Number
NCT06456242
Lead Sponsor
University of Kansas Medical Center
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MedCM plus CounsCMCounsCM+MedCM (Health Rewards)Mobile Contingency Management for counseling attendance and medication intake
Primary Outcome Measures
NameTimeMethod
Proportion of quitline calls completedWeek 6

Completion of the five quitline calls over 6 weeks of treatment according to Kansas quitline reports

Proportion of varenicline pills takenWeek 12

Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting

Secondary Outcome Measures
NameTimeMethod
Proportion of patients adherent to vareniclineWeek 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 takenWeek 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 abstinenceWeek 12

Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml

Proportion of patients with self-reported smoking abstinenceWeek 12

Past 7 days self-reported smoking abstinence

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