Incentivized Smoking Cessation for Diabetics

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527667
• Other study ID #: 8652
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

Description:

Individuals with type 2 diabetes (T2D) are at an increased risk of many cancers, though the causal link is not well understood. Continuing to smoke after a T2D diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. Smoking cessation is recommended as a standard treatment for diabetes. However, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting.

Contingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. This approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. This is a multicenter pilot randomized controlled trial that will recruit participants in Oklahoma and in Strathclyde, Scotland.

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered. Qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between UK and US health settings.

The results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. The ultimate aim is to develop an effective intervention that could be scaled to the T2D population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 75

• Type 2 diabetes diagnosis greater than 1 year prior to enrollment

• Currently smoking at least 5 cigarettes per day

• Self-reported quit attempt in past 12 months

Exclusion Criteria:

• Unwilling to make a quit attempt

• Unable to use smartphone iCO monitor following training session

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Smoking Cessation

Intervention

Behavioral:
• Financial incentives
Treatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated.

Locations

Country	Name	City	State
United Kingdom	University of Strathclyde	Glasgow	Scotland
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
University of Oklahoma	Cancer Research UK, University College, London, University of Strathclyde

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of CO readings completed	Feasibility of study determined by number of CO readings completed by each participant	12 weeks
Secondary	Quit outcomes	Proportion of participants who quit smoking	12 weeks
Secondary	Cigarettes per day	Reduction in cigarettes smoked per day	12 weeks