Smoking CessationCRUK2NCT04682067
Diabetes Smoking Cessation Incentives Study
A study testing Contingency Management in people with Smoking Cessation and Diabetes Type 2, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Diabetes Type 2
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 7 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to demonstrate use of or unwilling to use the remote CO monitor and phone app
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Tobacco Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Incentives to Promote Smoking Cessation for Individuals With Diabetes
The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.
Read the detailed description
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
- Smoking Cessation, Diabetes Type 2
- Being tested
- Contingency Management, Usual Care smoking cessation
- Keywords
- financial incentives, contingency management
- Medical subject headings
- Smoking Cessation, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Escalating financial incentives contingent upon biochemical evidence of abstinence
Usual Care smoking cessationBehavioural
Usual care smoking cessation support
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Usual Care smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing 6 study visits
Feasibility outcome: completion of 6 study visits
Measured: 5 weeks
Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed
Feasibility outcome: completion of EMA portion of study
Measured: 4 weeks
Secondary outcomes (1)
Number of participants with biochemically verified abstinence at 4 weeks post quit
Carbon Monoxide (CO) ≤ 6 ppm on exit date; self-reported 7-day point prevalence abstinence
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start8 Jan 2021
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney Martinez, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682067
- Sponsor's protocol ID
- 11582
- Acronym
- CRUK2
- Status last verified
- May 2022
- First submitted
- 18 Dec 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives to Promote Smoking Cessation for Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT04682067
- Acronym / sponsor ID
- CRUK2 / 11582
- Conditions
- Smoking Cessation, Diabetes Type 2
- Keywords
- financial incentives, contingency management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency Management, Behavioral: Usual Care smoking cessationParticipants 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). |
| Usual Care | Placebo comparator | Behavioral: Usual Care smoking cessationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- unable to demonstrate use of or unwilling to use the remote CO monitor and phone app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementEscalating financial incentives contingent upon biochemical evidence of abstinence | Behavioural | Contingency Management |
| Usual Care smoking cessationUsual care smoking cessation support | Behavioural | Contingency Management, Usual Care |
Primary outcome
Number of participants completing 6 study visits
Time frame: 5 weeks
Feasibility outcome: completion of 6 study visits
Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed
Time frame: 4 weeks
Feasibility outcome: completion of EMA portion of study
1 secondary outcome
Number of participants with biochemically verified abstinence at 4 weeks post quit
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Martinez, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Smoking Cessation and Diabetes Type 2, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing 6 study visits (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.