Smoking CessationNCT03608852
Unconventional Financial Incentives for Smoking Cessation
An observational study of Smoking Cessation, run by Miami VA Healthcare System.
Trial summary
The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Aug 2019
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The goal of this study is to enroll 36 active smokers
Who may be able to join
- Enrollment criteria include subjects 18 years of age or older, currently smoking at least a half a pack of cigarettes a day, who have at least a ten-pack year smoking history, are interested in quitting smoking, agree to submit to exhaled breath and ABG analysis and have reliable means of visiting the clinic every two weeks. Subjects must be able to tolerate NRT including patches and lozenges and meet with the VA smoking cessation counselor.
Who cannot join
- Subjects will not be enrolled if they are currently taking varenicline as the VA disallows concurrent use of varenicline and NRT.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bad is Stronger Than Good: Unconventional Financial Incentives for Smoking Cessation
The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Subjects are followed biweekly for smoking cessation by using biochemical tests (exCO and COHb) to determine smoking abstinence. The first group called the Banked-Money Group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. The second group called the Reward Group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.
- Conditions
- Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Banked-money group | This group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. | |
| Reward group | This group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate
The primary outcome for this study is to compare smoking cessation rates between smokers who received one of two financial incentive strategies in addition to standard of care NRT and counseling.
Measured: 1 year
Secondary outcomes (5)
Household income
We will determine whether household income affect quit rates.
Measured: 1 year
Smoking habits
We will determine whether smoking habits affect quit rates.
Measured: 1 year
Nicotine dependence
We will determine whether nicotine dependence affect quit rates.
Measured: 1 year
Nicotine withdrawal symptoms
We will determine whether nicotine withdrawal symptoms affect quit rates.
Measured: 1 year
Anxiety / Depression
We will determine whether anxiety and / or depression affect quit rates.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Aug 2019 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miami VA Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Gregory Holt, Miami VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608852
- Sponsor's protocol ID
- 1160736-1
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bad is Stronger Than Good: Unconventional Financial Incentives for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03608852
- Acronym / sponsor ID
- 1160736-1
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Miami VA Healthcare SystemUS federal agency
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 1 Aug 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.
The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Subjects are followed biweekly for smoking cessation by using biochemical tests (exCO and COHb) to determine smoking abstinence. The first group called the Banked-Money Group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. The second group called the Reward Group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banked-money group | – | –This group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. |
| Reward group | – | –This group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The goal of this study is to enroll 36 active smokers
Key inclusion criteria (1 listed)
- Enrollment criteria include subjects 18 years of age or older, currently smoking at least a half a pack of cigarettes a day, who have at least a ten-pack year smoking history, are interested in quitting smoking, agree to submit to exhaled breath and ABG analysis and have reliable means of visiting the clinic every two weeks. Subjects must be able to tolerate NRT including patches and lozenges and meet with the VA smoking cessation counselor.
Key exclusion criteria (1 listed)
- Subjects will not be enrolled if they are currently taking varenicline as the VA disallows concurrent use of varenicline and NRT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smoking cessation rate
Time frame: 1 year
The primary outcome for this study is to compare smoking cessation rates between smokers who received one of two financial incentive strategies in addition to standard of care NRT and counseling.
5 secondary outcomes
Household income
Time frame: 1 year
Smoking habits
Time frame: 1 year
Nicotine dependence
Time frame: 1 year
Nicotine withdrawal symptoms
Time frame: 1 year
Anxiety / Depression
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Miami VA Healthcare System.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel A Vital, MD (305-575-7000 ext. 4816, isabel.vital@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rate (time frame: 1 year). 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 1 Aug 2018.