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Clinical Trials/NCT05072301
NCT05072301CompletedNot Applicable

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

Yale University3 sites in 2 countries87 target enrollmentStarted: October 13, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
3
Primary Endpoint
Breath Carbon Monoxide Test (measured in ppm levels)

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Reduced smoking(14 days following intake date, as well as 1 month and 6 months after intake date)
  • Attrition(14 days following intake date)
  • Time to first relapse(14 days following intake date)
  • Contingency Management Payment(14 days following intake date)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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