Clinical trial NCT03527667: Incentivized Smoking Cessation for Diabetics
Official title: Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Diabetes Mellitus, Type 2
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: University of Strathclyde
name: University College, London
First posted: 2018-05-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of CO readings completed
timeFrame: 12 weeks
Secondary outcomes:
measure: Quit outcomes
timeFrame: 12 weeks
measure: Cigarettes per day
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Glasgow
country: United Kingdom
facility: University of Strathclyde
state: Scotland
Study officials:
affiliation: University of Oklahoma
name: Sydney A Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.