Diabetes Smoking Cessation Incentives Study (CRUK2)

University of Oklahoma (OU)

Status: Completed

Conditions: Diabetes Type 2; Smoking Cessation

Treatments: Behavioral: Contingency Management; Behavioral: Usual Care smoking cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT04682067

11582 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups, including a placebo group

Contingency Management

Experimental group

Description:

Participants in the contingency management (CM) treatment arm will receive the usual care (UC) treatment program offered at the Tobacco Treatment Research Program (TTRP) and will be eligible to earn gift cards at each weekly visit on their quit date up until four weeks post-quit for proof of abstinence. They will earn $20 in gift cards for quitting on the specified quit day (i.e., one week after the orientation visit), and this amount will increase by $5 with each successive weekly abstinent visit (i.e., up to $40 in gift cards at 4 weeks post-quit; up to $150 total).

Treatment:

Behavioral: Contingency Management

Behavioral: Usual Care smoking cessation

Usual Care

Placebo Comparator group

Description:

Participants in the usual care (UC) group will receive the standard smoking cessation treatment offered at the Health Promotion Research Center's Tobacco Treatment Research Program (TTRP) at the University of Oklahoma. This includes at least 4 treatment sessions of counseling and the opportunity to use nicotine replacement therapy or medications.

Treatment:

Behavioral: Usual Care smoking cessation