Clinical trial NCT06456242: Contingency Management to Promote Smoking Cessation
Official title: Using Contingency Management to Promote Adherence to Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Oklahoma
First posted: 2024-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of quitline calls completed
timeFrame: Week 6
measure: Proportion of varenicline pills taken
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of patients adherent to varenicline
timeFrame: Week 3
measure: Proportion of self-reported varenicline pills taken
timeFrame: Week 3
measure: Proportion of patients with biochemically verified smoking abstinence
timeFrame: Week 12
measure: Proportion of patients with self-reported smoking abstinence
timeFrame: Week 12
Other outcomes:
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