Contingency Management to Promote Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Using Contingency Management to Promote Adherence to Smoking Cessation Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456242
• Other study ID #: DA055779
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: Erica Cruvinel
• Phone: 913-945-6966
• Email: ecruvinel[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• CounsCM+MedCM (Health Rewards)
Small financial incentives for completing quitline calls (CounsCM) plus small financial incentives for taking varenicline (MedCM).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Drug Abuse (NIDA), University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of quitline calls completed	Completion of the five quitline calls over 6 weeks of treatment according to Kansas quitline reports	Week 6
Primary	Proportion of varenicline pills taken	Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting	Week 12
Secondary	Proportion of patients adherent to varenicline	Adherence biochemically verified using saliva samples, 1.0 ng/ml as the cutoff to distinguish between participants adherent and adherent	Week 3
Secondary	Proportion of self-reported varenicline pills taken	Self-reported use of varenicline from a timeline followback questionnaire assessing varenicline pills taken in each of the past 3 days	Week 3
Secondary	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
Secondary	Proportion of patients with self-reported smoking abstinence	Past 7 days self-reported smoking abstinence	Week 12