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NCT Number: NCT07685899

Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical 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.

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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

Location contact

Erica Cruvinel

CONTACT

[email protected]

913-526-0774

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)
  • 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

Health Rewards

Behavioral

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).

Control

Behavioral

All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.

Primary outcomes

  1. Feasibility outcomes

    Time frame: 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.

  2. Proportion of quitline calls completed

    Time frame: Week 12

    Completion of the five quitline calls according to Kansas quitline reports

  3. 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 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

  2. Proportion of patients with self-reported smoking abstinence

    Time frame: Week 12

    Past 7 days self-reported smoking abstinence

Study contacts

Contact information is provided by the study sponsor or research team.

Erica Cruvinel

CONTACT

[email protected]

913-945-6966

Vinita Devarasetty, MPH

CONTACT

[email protected]

913-617-1018

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 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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