Diabetes Smoking Cessation Incentives Study (CRUK2)

Incentives to Promote Smoking Cessation for Individuals With Diabetes

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Diabetes Type 2
• Intervention / Treatment: Behavioral: Contingency Management; Behavioral: Usual Care smoking cessation

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Tobacco Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; 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).	Behavioral: Contingency Management; Escalating financial incentives contingent upon biochemical evidence of abstinence; Behavioral: Usual Care smoking cessation; Usual care smoking cessation support
Placebo Comparator: Usual Care; 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.	Behavioral: Usual Care smoking cessation; Usual care smoking cessation support

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Sydney Martinez, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: financial incentives; contingency management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 11582 (REB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No