Contingency Management to Promote Smoking Cessation

NCT ID: NCT06456242

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-01-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MedCM plus CounsCM

Mobile Contingency Management for counseling attendance and medication intake

Group Type: EXPERIMENTAL

CounsCM+MedCM (Health Rewards)

Intervention Type: BEHAVIORAL

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

Interventions

CounsCM+MedCM (Health Rewards)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erica Cruvinel

Role: CONTACT

ecruvinel@kumc.edu

913-945-6966

Vinita Devarasetty, MPH

Role: CONTACT

v210d808@kumc.edu

913-617-1018

Facility Contacts

Erica Cruvinel

Role: primary

ecruvinel@kumc.edu

913-526-0774

Other Identifiers

DA055779

Identifier Type: -

Identifier Source: org_study_id