Diabetes Smoking Cessation Incentives Study

NCT04682067 | Completed

• 1 other identifier: 11582
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation; Diabetes Type 2

Keywords

financial incentives; contingency management

Outcome Measures

Primary Outcomes (2)

• Number of participants completing 6 study visits

  Feasibility outcome: completion of 6 study visits

  5 weeks

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

  Feasibility outcome: completion of EMA portion of study

  4 weeks

Secondary Outcomes (1)

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

  5 weeks

Study Arms (2)

Contingency Management

EXPERIMENTAL

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).

Behavioral: Contingency Management; Behavioral: Usual Care smoking cessation

Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Usual Care smoking cessation

Interventions

Contingency Management BEHAVIORAL

Escalating financial incentives contingent upon biochemical evidence of abstinence

Contingency Management

Usual Care smoking cessation BEHAVIORAL

Usual care smoking cessation support

Contingency Management; Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: The study has no inclusion/exclusion criteria based on gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to demonstrate use of or unwilling to use the remote CO monitor and phone app

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sydney Martinez, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: January 8, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)