Diabetes Smoking Cessation Incentives Study

N/ACompletedNCT04682067

University of Oklahoma29 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Smoking Cessation Diabetes Type 2

Interventions

Contingency ManagementBEHAVIORAL

Escalating financial incentives contingent upon biochemical evidence of abstinence

Usual Care smoking cessationBEHAVIORAL

Usual care smoking cessation support

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Number of participants completing 6 study visits

Feasibility outcome: completion of 6 study visits

Time frame: 5 weeks

Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed

Feasibility outcome: completion of EMA portion of study

Time frame: 4 weeks

Secondary Outcomes

Number of participants with biochemically verified abstinence at 4 weeks post quit

Carbon Monoxide (CO) ≤ 6 ppm on exit date; self-reported 7-day point prevalence abstinence

Time frame: 5 weeks

Data from ClinicalTrials.gov

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