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OpenTrials
Completed

NCT Number: NCT05072301

Preliminary Test of Reactive Carrot Incentives in a Practice Quit Environment With Contingency Management Incentives

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ukraine site, Kiev, Ukraine

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contingency Management

Behavioral

The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future.

Control

Behavioral

The control group will receive contingency management payments and other monetary benefits for completing the trial.

Primary outcomes

  1. 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.

  2. Proportion of CO (CO ≤ 4ppm)

    Time frame: 14 days following intake date

    Proportion of 6 CO tests showing abstinence (CO ≤ 4ppm)

  3. 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

Secondary outcomes

  1. Attrition

    Time frame: 14 days following intake date

    Attrition will be measured by participants ability to make their testing appointments.

  2. Contingency Management Payment

    Time frame: 14 days following intake date

    Total amount of abstention (contingency management) rewards paid to subjects.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2021
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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