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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Health Rewards; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erica Cruvinel; Phone Number: 913-945-6966; Email: ecruvinel@kumc.edu
• Study Contact Backup: Name: Vinita Devarasetty, MPH; Phone Number: 913-617-1018; Email: v210d808@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
      • Contact: Erica Cruvinel; Phone Number: 913-526-0774; Email: ecruvinel@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CounsCM+MedCM; Mobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM)	Behavioral: Health 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).
Active Comparator: Control; 12 weeks of varenicline and referral to state quitline	Behavioral: Control; All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of varenicline pills taken	Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting	Week 12
Feasibility outcomes	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.	Week 3 to 12
Proportion of quitline calls completed	Completion of the five quitline calls according to Kansas quitline reports	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with biochemically verified smoking abstinence	Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml	Week 12
Proportion of patients with self-reported smoking abstinence	Past 7 days self-reported smoking abstinence	Week 12

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); University of Oklahoma; University of Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation
• Other Study ID Numbers: DA055779-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No