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OpenTrials
Completed

NCT Number: NCT06456242

Contingency Management to Promote Smoking Cessation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CounsCM+MedCM (Health Rewards)

Behavioral

Small financial incentives for completing quitline calls (CounsCM) plus small financial incentives for taking varenicline (MedCM).

Primary outcomes

  1. Proportion of quitline calls completed

    Time frame: Week 6

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

  2. Proportion of varenicline pills taken

    Time frame: Week 12

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

Secondary outcomes

  1. Proportion of patients adherent to varenicline

    Time frame: Week 3

    Adherence biochemically verified using saliva samples, 1.0 ng/ml as the cutoff to distinguish between participants adherent and adherent

  2. Proportion of self-reported varenicline pills taken

    Time frame: Week 3

    Self-reported use of varenicline from a timeline followback questionnaire assessing varenicline pills taken in each of the past 3 days

  3. Proportion of patients with biochemically verified smoking abstinence

    Time frame: Week 12

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

  4. Proportion of patients with self-reported smoking abstinence

    Time frame: Week 12

    Past 7 days self-reported smoking abstinence

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Oklahoma

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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