Smoking CessationNCT05072301
Preliminary Test of Reactive Carrot Incentives in a Practice Quit Environment With Contingency Management Incentives
A study testing Contingency Management in people with Smoking Cessation, run by Yale University at 2 sites in 2 countries.
Trial summary
The primary aim of this study is to pilot test a novel reactive carrot approach for improving individuals' ability to stick to a "practice quit" program in a smoking cessation context. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- 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
- 87 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Oct 2021to 3 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Smoke ≥ 3 cigarettes per week and expressing interest in quitting smoking.
Who cannot join
- Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
- unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
- pregnant or breastfeeding women
- those with limited decision making capacity.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
General New Haven Public
New Haven, Connecticut, 06512
About this study
The primary aim of this study is to pilot test a novel reactive carrot approach for improving individuals' ability to stick to a "practice quit" program in a smoking cessation context. In this study, the treatment gives subjects an offer to forego a monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards.
Read the detailed description
All the subjects, treatment and control groups, would be given the opportunity to receive attendance rewards for attending six CO testing meetings as well as abstention (contingency management) rewards for abstaining from smoking. The only difference between the subjects randomly assigned to treatment and control groups is that each member of the treatment group would be tempted at the beginning of their program by being offered a one-time monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards. Treatment group subjects would, at their initial intake meeting after the attendance and abstention rewards opportunity had been described, be given a one-time opportunity to received $80 temptation payment to give up the opportunity to receive subsequent abstinence (contingency management) rewards that could be worth as much as $165. Subjects who accepted this one-time opportunity would remain enrolled in the practice quit smoking and they would still be eligible to receive attendance reward compensation totaling up to $30 for showing up to their six testing appointments. The purpose of the study is to test whether resisting the temptation to accept the one-time payment helps steel the resolve of the treatment subjects to follow through and make sure that they earn the subsequent contingency management rewards. More specifically, an intent-to-treat design will allow us to test whether the temptation causes treatment group subjects to have greater success than the un-tempted control group subjects to abstain from smoking during the two-week practice quit period.
- Conditions
- Smoking Cessation
- Being tested
- Contingency Management, Control
- Keywords
- incentives
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future.
ControlBehavioural
The control group will receive contingency management payments and other monetary benefits for completing the trial.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future. Receives: Behavioral: Contingency Management |
| Control | Placebo comparator | The control group will receive contingency management payments and other monetary benefits for completing the trial. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Carbon Monoxide Test (measured in ppm levels)
A primary outcome is the sum of times a subject tested abstinent at the 6 CO testing meetings. To test for abstinence, a breath carbon monoxide test will be used to determine exposure to smoke. Abstinence will be coded as expired-air carbon monoxide (CO) levels below 5 ppm.
Measured: 14 days following intake date
Proportion of CO (CO ≤ 4ppm)
Proportion of 6 CO tests showing abstinence (CO ≤ 4ppm)
Measured: 14 days following intake date
Maximum number of consecutive abstinent days
The maximum number of consecutive abstinent days for each subject will be measured
Measured: 14 days following intake date
Secondary outcomes (4)
Attrition
Attrition will be measured by participants ability to make their testing appointments.
Measured: 14 days following intake date
Contingency Management Payment
Total amount of abstention (contingency management) rewards paid to subjects.
Measured: 14 days following intake date
Time to first relapse
Time to first relapse will be measured by subjects self-reporting use of different types of tobacco products or cigarette alternatives
Measured: 14 days following intake date
Reduced smoking
Whether subjects report reduced smoking will be used to measure reduced smoking habits
Measured: 14 days following intake date, as well as 1 month and 6 months after intake date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start13 Oct 2021
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
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 Yale UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Ayres, PhD, Principal investigator, Yale Law SchoolGiuseppe Mattiacci, PhD, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072301
- Sponsor's protocol ID
- 2000030430
- Status last verified
- Aug 2023
- First submitted
- 30 Sep 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Test of Reactive Carrot Incentives in a Practice Quit Environment With Contingency Management Incentives
- ClinicalTrials.gov ID
- NCT05072301
- Acronym / sponsor ID
- 2000030430
- Conditions
- Smoking Cessation
- Keywords
- incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 8 Oct 2021 (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 primary aim of this study is to pilot test a novel reactive carrot approach for improving individuals' ability to stick to a "practice quit" program in a smoking cessation context. In this study, the treatment gives subjects an offer to forego a monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards.
Detailed description
All the subjects, treatment and control groups, would be given the opportunity to receive attendance rewards for attending six CO testing meetings as well as abstention (contingency management) rewards for abstaining from smoking. The only difference between the subjects randomly assigned to treatment and control groups is that each member of the treatment group would be tempted at the beginning of their program by being offered a one-time monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards. Treatment group subjects would, at their initial intake meeting after the attendance and abstention rewards opportunity had been described, be given a one-time opportunity to received $80 temptation payment to give up the opportunity to receive subsequent abstinence (contingency management) rewards that could be worth as much as $165. Subjects who accepted this one-time opportunity would remain enrolled in the practice quit smoking and they would still be eligible to receive attendance reward compensation totaling up to $30 for showing up to their six testing appointments. The purpose of the study is to test whether resisting the temptation to accept the one-time payment helps steel the resolve of the treatment subjects to follow through and make sure that they earn the subsequent contingency management rewards. More specifically, an intent-to-treat design will allow us to test whether the temptation causes treatment group subjects to have greater success than the un-tempted control group subjects to abstain from smoking during the two-week practice quit period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementThe treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future. |
| Control | Placebo comparator | Behavioral: ControlThe control group will receive contingency management payments and other monetary benefits for completing the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Smoke ≥ 3 cigarettes per week and expressing interest in quitting smoking.
Key exclusion criteria (4 listed)
- Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
- unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
- pregnant or breastfeeding women
- those with limited decision making capacity.
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 ManagementThe treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future. | Behavioural | Contingency Management |
| ControlThe control group will receive contingency management payments and other monetary benefits for completing the trial. | Behavioural | Control |
Primary outcome
Breath Carbon Monoxide Test (measured in ppm levels)
Time frame: 14 days following intake date
A primary outcome is the sum of times a subject tested abstinent at the 6 CO testing meetings. To test for abstinence, a breath carbon monoxide test will be used to determine exposure to smoke. Abstinence will be coded as expired-air carbon monoxide (CO) levels below 5 ppm.
Proportion of CO (CO ≤ 4ppm)
Time frame: 14 days following intake date
Proportion of 6 CO tests showing abstinence (CO ≤ 4ppm)
Maximum number of consecutive abstinent days
Time frame: 14 days following intake date
The maximum number of consecutive abstinent days for each subject will be measured
4 secondary outcomes
Attrition
Time frame: 14 days following intake date
Contingency Management Payment
Time frame: 14 days following intake date
Time to first relapse
Time frame: 14 days following intake date
Reduced smoking
Time frame: 14 days following intake date, as well as 1 month and 6 months after intake date
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 1 Sep 2023.
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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.
Ian Ayres, PhD principal investigator
Yale Law School
Giuseppe Mattiacci, PhD principal investigator
University of Amsterdam
2 sites in 2 countries: 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, run by Yale University 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 2 inclusion and 4 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 1 Sep 2023. 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, Ukraine. 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?
Breath Carbon Monoxide Test (measured in ppm levels) (time frame: 14 days following intake date). The study lists 3 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 1 Sep 2023.