- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05072301
Preliminary Test of Reactive Carrot Incentives in a Practice Quit Environment With Contingency Management Incentives
August 31, 2023 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kiev, Ukraine
- Ukraine site
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Connecticut
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New Haven, Connecticut, United States, 06512
- General New Haven Public
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ≥ 18 years
- Smoke ≥ 3 cigarettes per week and expressing interest in quitting smoking.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contingency Management
The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future.
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The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future.
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Placebo Comparator: Control
The control group will receive contingency management payments and other monetary benefits for completing the trial.
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The control group will receive contingency management payments and other monetary benefits for completing the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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14 days following intake date
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Proportion of CO (CO ≤ 4ppm)
Time Frame: 14 days following intake date
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Proportion of 6 CO tests showing abstinence (CO ≤ 4ppm)
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14 days following intake date
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Maximum number of consecutive abstinent days
Time Frame: 14 days following intake date
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The maximum number of consecutive abstinent days for each subject will be measured
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14 days following intake date
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Attrition
Time Frame: 14 days following intake date
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Attrition will be measured by participants ability to make their testing appointments.
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14 days following intake date
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Contingency Management Payment
Time Frame: 14 days following intake date
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Total amount of abstention (contingency management) rewards paid to subjects.
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14 days following intake date
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Time to first relapse
Time Frame: 14 days following intake date
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Time to first relapse will be measured by subjects self-reporting use of different types of tobacco products or cigarette alternatives
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14 days following intake date
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Reduced smoking
Time Frame: 14 days following intake date, as well as 1 month and 6 months after intake date
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Whether subjects report reduced smoking will be used to measure reduced smoking habits
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14 days following intake date, as well as 1 month and 6 months after intake date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian Ayres, PhD, Yale Law School
- Principal Investigator: Giuseppe Mattiacci, PhD, University of Amsterdam
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2021
Primary Completion (Actual)
January 3, 2023
Study Completion (Actual)
January 3, 2023
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
September 30, 2021
First Posted (Actual)
October 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000030430
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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