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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072301
• Other study ID #: 2000030430
• Status: Completed
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: January 3, 2023

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
Ukraine	Ukraine site	Kiev
United States	General New Haven Public	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Countries where clinical trial is conducted

United States,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days following intake date
Primary	Proportion of CO (CO = 4ppm)	Proportion of 6 CO tests showing abstinence (CO = 4ppm)	14 days following intake date
Primary	Maximum number of consecutive abstinent days	The maximum number of consecutive abstinent days for each subject will be measured	14 days following intake date
Secondary	Attrition	Attrition will be measured by participants ability to make their testing appointments.	14 days following intake date
Secondary	Contingency Management Payment	Total amount of abstention (contingency management) rewards paid to subjects.	14 days following intake date
Secondary	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	14 days following intake date
Secondary	Reduced smoking	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