NCT06456242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

June 4, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Proportion of quitline calls completed

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

    Week 6

  • Proportion of varenicline pills taken

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

    Week 12

Secondary Outcomes (4)

  • Proportion of patients adherent to varenicline

    Week 3

  • Proportion of self-reported varenicline pills taken

    Week 3

  • Proportion of patients with biochemically verified smoking abstinence

    Week 12

  • Proportion of patients with self-reported smoking abstinence

    Week 12

Study Arms (1)

MedCM plus CounsCM

EXPERIMENTAL

Mobile Contingency Management for counseling attendance and medication intake

Behavioral: CounsCM+MedCM (Health Rewards)

Interventions

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

MedCM plus CounsCM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 13, 2024

Study Start

September 20, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations