Smoking CessationNCT05738408
Remote Smoking Cessation in Hospitalized Cardiac Patients
A study testing Financial Incentives (FI) and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be recruited if they:
- Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)
- live within 30 miles of UVMMC and are >18 years of age
- Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and >5 cigarette/day on average over the past 3 months)
Who cannot join
- Patients will be excluded if they have:
- severe dementia/Alzheimer's disease
- an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance
- exercise limiting vascular or neuromuscular disease
- Non-English Speaking
- No reliable smart-phone
- Current, regular use of smokeless tobacco or other form of non-combusted tobacco
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diann Gaalema, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05405
Sherrie Khadanga, 802-847-2700, sherrie.khadanga@uvmhealth.org
About this study
Official title: Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge
The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease
Read the detailed description
Cigarette smoking is the leading cause of preventable death in the U.S. The effect of smoking in those with coronary artery disease (CAD) is particularly powerful given that at hospital admission, 27-36% of these patients are active smokers which is much higher than in the general population (<18%).1-3While smoking rates have declined in the U.S., this has not been observed in cardiac populations. Continued smoking after hospitalization also predicts additional negative outcomes such as lack of engagement in comprehensive secondary prevention for example cardiac rehabilitation (CR).4 Smoking may also directly impede improvements in fitness which is a critical predictor of recovery in this population and thus crucial to examine.5-7 Surprisingly, having a serious cardiac event, such as a myocardial infarction (MI) may not be enough to promote sustained cessation.8 Thus, promoting adherence to smoking cessation guidelines in this population is of utmost importance.9
Acute cardiac hospitalization does provide an ideal opportunity to intervene on smoking.10 Patients are required to abstain from smoking while hospitalized and are often motivated to quit. Unfortunately, less than a quarter of patients receive Nicotine Replacement Therapy (NRT) in-hospital and even fewer receive support after discharge. 11,12 For most patients, follow-up care may not occur for 4-6 weeks and most patients relapse to smoking within the first few weeks.11,13 Ideally, intensive intervention would be started in-hospital and continue after discharge, bridging this post-hospital gap in care.
Financial incentives (FI) for objectively verified smoking abstinence is highly effective in promoting smoking cessation in medically vulnerable populations, but, to the Investigators knowledge, has not been tested in patients with CVD.14.15 NRT is safe in cardiac patients, but is rarely prescribed or offered in a manner that maximizes efficacy (i.e., combination short and long-acting NRT).16 Building on our strong published and preliminary data, the investigators hypothesize that a combined behavioral and pharmacologic smoking cessation intervention started in hospital and continued remotely can bridge the post-hospital care gap and support patients through a critical period in cardiac recovery where risk of smoking relapse is high.
- Conditions
- Smoking Cessation
- Being tested
- Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)
- Keywords
- smoking cessation, secondary prevention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)Behavioural
: In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff
| Study group | Role | What they receive |
|---|---|---|
| Control: Usual Care | No intervention | will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan |
| Intervention: Financial incentives and nicotine replacement therapy intervention | Experimental | an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence Receives: Behavioral: Financial Incentives (FI) and Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical verification of smoking status
Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence
Measured: 3 months
Secondary outcomes (1)
Cardiovascular Fitness
Determine the effect of smoking status on changes in cardiovascular fitness (VO2peak).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start12 Aug 2022
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherrie Khadanga, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738408
- Sponsor's protocol ID
- STUDY00002035
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge
- ClinicalTrials.gov ID
- NCT05738408
- Acronym / sponsor ID
- STUDY00002035
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, secondary prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Feb 2023 (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 investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease
Detailed description
Cigarette smoking is the leading cause of preventable death in the U.S. The effect of smoking in those with coronary artery disease (CAD) is particularly powerful given that at hospital admission, 27-36% of these patients are active smokers which is much higher than in the general population (<18%).1-3While smoking rates have declined in the U.S., this has not been observed in cardiac populations. Continued smoking after hospitalization also predicts additional negative outcomes such as lack of engagement in comprehensive secondary prevention for example cardiac rehabilitation (CR).4 Smoking may also directly impede improvements in fitness which is a critical predictor of recovery in this population and thus crucial to examine.5-7 Surprisingly, having a serious cardiac event, such as a myocardial infarction (MI) may not be enough to promote sustained cessation.8 Thus, promoting adherence to smoking cessation guidelines in this population is of utmost importance.9
Acute cardiac hospitalization does provide an ideal opportunity to intervene on smoking.10 Patients are required to abstain from smoking while hospitalized and are often motivated to quit. Unfortunately, less than a quarter of patients receive Nicotine Replacement Therapy (NRT) in-hospital and even fewer receive support after discharge. 11,12 For most patients, follow-up care may not occur for 4-6 weeks and most patients relapse to smoking within the first few weeks.11,13 Ideally, intensive intervention would be started in-hospital and continue after discharge, bridging this post-hospital gap in care.
Financial incentives (FI) for objectively verified smoking abstinence is highly effective in promoting smoking cessation in medically vulnerable populations, but, to the Investigators knowledge, has not been tested in patients with CVD.14.15 NRT is safe in cardiac patients, but is rarely prescribed or offered in a manner that maximizes efficacy (i.e., combination short and long-acting NRT).16 Building on our strong published and preliminary data, the investigators hypothesize that a combined behavioral and pharmacologic smoking cessation intervention started in hospital and continued remotely can bridge the post-hospital care gap and support patients through a critical period in cardiac recovery where risk of smoking relapse is high.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Usual Care | No intervention | –will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan |
| Intervention: Financial incentives and nicotine replacement therapy intervention | Experimental | Behavioral: Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)
- live within 30 miles of UVMMC and are >18 years of age
- Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and >5 cigarette/day on average over the past 3 months)
Key exclusion criteria (7 listed)
- severe dementia/Alzheimer's disease
- an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance
- exercise limiting vascular or neuromuscular disease
- Non-English Speaking
- No reliable smart-phone
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 Incentives (FI) and Nicotine Replacement Therapy (NRT): In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff | Behavioural | Intervention: Financial incentives and nicotine replacement therapy intervention |
Primary outcome
Biochemical verification of smoking status
Time frame: 3 months
Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence
1 secondary outcome
Cardiovascular Fitness
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Diann Gaalema, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives (FI) and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, run by University of Vermont Medical Center 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherrie Khadanga, MD (802-847-2700, sherrie.khadanga@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical verification of smoking status (time frame: 3 months). 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 20 Jan 2025.