NCT05072301

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

October 13, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

September 30, 2021

Last Update Submit

August 31, 2023

Conditions

Keywords

incentives

Outcome Measures

Primary Outcomes (3)

  • 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

  • Proportion of CO (CO ≤ 4ppm)

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

    14 days following intake date

  • 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 Outcomes (4)

  • Attrition

    14 days following intake date

  • Contingency Management Payment

    14 days following intake date

  • Time to first relapse

    14 days following intake date

  • Reduced smoking

    14 days following intake date, as well as 1 month and 6 months after intake date

Study Arms (2)

Contingency Management

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

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

Contingency Management
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Smoke ≥ 3 cigarettes per week and expressing interest in quitting smoking.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General New Haven Public

New Haven, Connecticut, 06512, United States

Location

Ukraine site

Kiev, Ukraine

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ian Ayres, PhD

    Yale Law School

    PRINCIPAL INVESTIGATOR
  • Giuseppe Mattiacci, PhD

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 8, 2021

Study Start

October 13, 2021

Primary Completion

January 3, 2023

Study Completion

January 3, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations