Diabetes Smoking Cessation Incentives Study

Smoking Cessation Clinical Trial

— CRUK2  

Official title:

Incentives to Promote Smoking Cessation for Individuals With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682067
• Other study ID #: 11582
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: April 7, 2022

Study information

• Verified date: May 2022
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Smoking Cessation

Intervention

Behavioral:
• Contingency Management
Escalating financial incentives contingent upon biochemical evidence of abstinence
• Usual Care smoking cessation
Usual care smoking cessation support

Locations

Country	Name	City	State
United States	Oklahoma Tobacco Research Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants completing 6 study visits	Feasibility outcome: completion of 6 study visits	5 weeks
Primary	Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed	Feasibility outcome: completion of EMA portion of study	4 weeks
Secondary	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	5 weeks