Incentivized Smoking Cessation for Diabetics

Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Financial incentives

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom
      • University of Strathclyde
• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences 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:

• 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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short term incentives; usual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence	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.
Experimental: Long term incentives; usual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence	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.
No Intervention: No incentives; usual quit smoking treatment (counseling + medication)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of CO readings completed	Feasibility of study determined by number of CO readings completed by each participant	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quit outcomes	Proportion of participants who quit smoking	12 weeks
Cigarettes per day	Reduction in cigarettes smoked per day	12 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: University College, London; Cancer Research UK; University of Strathclyde
• Investigators: Principal Investigator: Sydney A Martinez, PhD, University of Oklahoma

Publications and helpful links

General Publications

• Martinez SA, Quaife SL, Hasan A, McMillan KA, Beebe LA, Muirhead F. Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial. Pilot Feasibility Stud. 2020 Jun 11;6:82. doi: 10.1186/s40814-020-00629-7. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 8652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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