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Completed

NCT Number: NCT04682067

Diabetes Smoking Cessation Incentives Study

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

Escalating financial incentives contingent upon biochemical evidence of abstinence

Usual Care smoking cessation

Behavioral

Usual care smoking cessation support

Primary outcomes

  1. Number of participants completing 6 study visits

    Time frame: 5 weeks

    Feasibility outcome: completion of 6 study visits

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

    Time frame: 4 weeks

    Feasibility outcome: completion of EMA portion of study

Secondary outcomes

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

    Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Incentives to Promote Smoking Cessation for Individuals With Diabetes

Acronym: CRUK2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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