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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ukraine
      • Kiev, Ukraine
        • Ukraine site
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • General New Haven Public

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
Placebo Comparator: Control
The control group will receive contingency management payments and other monetary benefits for completing the trial.
Behavioral: Control
The control group will receive contingency management payments and other monetary benefits for completing the trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
14 days following intake date
Proportion of CO (CO ≤ 4ppm)
Time Frame: 14 days following intake date
Proportion of 6 CO tests showing abstinence (CO ≤ 4ppm)
14 days following intake date
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
14 days following intake date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attrition
Time Frame: 14 days following intake date
Attrition will be measured by participants ability to make their testing appointments.
14 days following intake date
Contingency Management Payment
Time Frame: 14 days following intake date
Total amount of abstention (contingency management) rewards paid to subjects.
14 days following intake date
Time to first relapse
Time Frame: 14 days following intake date
Time to first relapse will be measured by subjects self-reporting use of different types of tobacco products or cigarette alternatives
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
Whether subjects report reduced smoking will be used to measure reduced smoking habits
14 days following intake date, as well as 1 month and 6 months after intake date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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