Diabetes Smoking Cessation Incentives Study

Not Applicable

Completed

• Conditions: Diabetes Type 2; Smoking Cessation

• Registration Number: NCT04682067
• Lead Sponsor: University of Oklahoma

Brief Summary

The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.

Detailed Description

Type 2 diabetes (T2DM) and cigarette smoking are major causes of morbidity and mortality in US, and research indicates there is a complex relationship between these two risk factors. Smoking cessation is recommended as a standard treatment of diabetes by the American Diabetes Association; however, patients with T2DM and their providers are often inundated with other challenging lifestyle changes and disease management. Due to the complex relationship between diabetes and smoking and the large number of competing lifestyle changes recommended at diagnosis, smokers with T2DM may benefit from a contingency management (CM) program that incentivizes cessation. Providing patients tangible rewards to reinforce positive behaviors such as smoking abstinence has been proven effective in substance abuse programs, smoking cessation among pregnant women unwilling or unable to quit, and other population subgroups. In this CRUK2 study the investigators aim to test and further explore the potential effectiveness of financial incentives contingent upon proof of quitting smoking. The investigators will gather diabetes-related contextual factors associated with participation in the program and smoking cessation.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-01-08
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Diagnosed with type 2 diabetes
• earn a score > 4 on REALM indicating > 6th grade English literacy level
• willing to quit smoking 7 days from their first visit
• have an expired CO level >8 ppm suggestive of current smoking at baseline
• currently smoking > 5 cigarettes per day
• willing and able to attend 6 study visits

Exclusion Criteria

• unable to demonstrate use of or unwilling to use the remote CO monitor and phone app

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants completing 6 study visits	5 weeks	Feasibility outcome: completion of 6 study visits
Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed	4 weeks	Feasibility outcome: completion of EMA portion of study

Secondary Outcome Measures

Name	Time	Method
Number of participants with biochemically verified abstinence at 4 weeks post quit	5 weeks	Carbon Monoxide (CO) ≤ 6 ppm on exit date; self-reported 7-day point prevalence abstinence

Trial Locations

Locations (1)

Oklahoma Tobacco Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States