Diabetes Smoking Cessation Incentives Study

NCT ID: NCT04682067

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2022-04-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking Cessation Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Contingency Management

Intervention Type BEHAVIORAL

Escalating financial incentives contingent upon biochemical evidence of abstinence

Usual Care smoking cessation

Intervention Type BEHAVIORAL

Usual care smoking cessation support

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.

Group Type PLACEBO_COMPARATOR

Usual Care smoking cessation

Intervention Type BEHAVIORAL

Usual care smoking cessation support

Interventions

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Contingency Management

Escalating financial incentives contingent upon biochemical evidence of abstinence

Intervention Type BEHAVIORAL

Usual Care smoking cessation

Usual care smoking cessation support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sydney Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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11582

Identifier Type: -

Identifier Source: org_study_id

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