Smoking CessationNCT03527667
Incentivized Smoking Cessation for Diabetics
A study testing Financial incentives in people with Smoking Cessation and Diabetes Mellitus, Type 2, run by University of Oklahoma at 2 sites in 2 countries.
Trial 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. 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 Mellitus, Type 2
- What is being tested?
- Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jun 2018to 30 Jun 2019
- 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
- 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
Who cannot join
- Unwilling to make a quit attempt
- Unable to use smartphone iCO monitor following training session
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Diabetes Mellitus, Type 2
- Being tested
- Financial incentives
- 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.
Financial incentivesBehavioural
Treatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated.
| Study group | Role | What they receive |
|---|---|---|
| Short term incentives | Experimental | usual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence Receives: Behavioral: Financial incentives |
| Long term incentives | Experimental | usual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence Receives: Behavioral: Financial incentives |
| No incentives | No intervention | usual quit smoking treatment (counseling + medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of CO readings completed
Feasibility of study determined by number of CO readings completed by each participant
Measured: 12 weeks
Secondary outcomes (2)
Quit outcomes
Proportion of participants who quit smoking
Measured: 12 weeks
Cigarettes per day
Reduction in cigarettes smoked per day
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start22 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- 3-arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, University of Strathclyde, University College, London
- Responsible party
- Sponsor
- Investigators
- Sydney A Martinez, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527667
- Sponsor's protocol ID
- 8652
- Status last verified
- Dec 2019
- First submitted
- 4 May 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32537238
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics
- ClinicalTrials.gov ID
- NCT03527667
- Acronym / sponsor ID
- 8652
- Conditions
- Smoking Cessation, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Cancer Research UK, University of Strathclyde, University College, London
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 17 May 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Short term incentives | Experimental | Behavioral: Financial incentivesusual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence |
| Long term incentives | Experimental | Behavioral: Financial incentivesusual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence |
| No incentives | No intervention | –usual quit smoking treatment (counseling + medication) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to make a quit attempt
- Unable to use smartphone iCO monitor following training session
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 |
|---|---|---|
| Financial incentivesTreatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated. | Behavioural | Long term incentives, Short term incentives |
Primary outcome
Proportion of CO readings completed
Time frame: 12 weeks
Feasibility of study determined by number of CO readings completed by each participant
2 secondary outcomes
Quit outcomes
Time frame: 12 weeks
Cigarettes per day
Time frame: 12 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 6 Dec 2019.
- Derived from this study: PubMed 32537238Martinez 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.
- Individual participant dataSharing planned: No
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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 A Martinez, PhD principal investigator
University of Oklahoma
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives in people with Smoking Cessation and Diabetes Mellitus, Type 2, run by University of Oklahoma at 2 sites in 2 countries.
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 4 inclusion and 2 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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. 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?
Proportion of CO readings completed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527667, which also lists 1 linked publication.
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 6 Dec 2019.