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

NCT07685899 | Not Yet Recruiting DMC

• 1 other identifier: DA055779-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• 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

• Proportion of varenicline pills taken

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

  Week 12

Secondary Outcomes (2)

• Proportion of patients with biochemically verified smoking abstinence

  Week 12

• Proportion of patients with self-reported smoking abstinence

  Week 12

Study Arms (2)

CounsCM+MedCM

EXPERIMENTAL

Mobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM)

Behavioral: Health Rewards

Control

ACTIVE COMPARATOR

12 weeks of varenicline and referral to state quitline

Behavioral: Control

Interventions

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).

CounsCM+MedCM

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Toronto: collaborator
• University of Kansas Medical Center: lead
• University of Oklahoma: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Erica Cruvinel

CONTACT

913-945-6966; ecruvinel@kumc.edu

Vinita Devarasetty, MPH

CONTACT

913-617-1018; v210d808@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

US (1)