Financial Incentives for Smoking Treatment II

NCT ID: NCT03979885

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1058 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Financial incentives for motivating changes in health behavior, particularly for smoking and other morbid habits, are increasingly being tested by health insurers, employers, and government agencies. However, in using incentive programs for smoking cessation, key unanswered structural and theoretical questions remain regarding their effectiveness, acceptability to patients, and economic sustainability. This trial aims to advance the science and implementation of financial incentives for smoking cessation interventions among high-risk, hospitalized smokers. The investigators will pursue two specific aims: 1) comparing the impact of three approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life and 2) comparing the short-term and long term return on investment of using goal directed and outcome-based financial incentives to promote smoking cessation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Tobacco Use Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Goal-Directed Incentives

Group Type OTHER

Smoking cessation counseling (Quitline)

Intervention Type BEHAVIORAL

Quitline offers community-based counseling session with a cessation counselor.

Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

Intervention Type BEHAVIORAL

Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.

Financial incentives for use of evidence-based smoking cessation therapies

Intervention Type BEHAVIORAL

Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies

Outcome-Based Incentives

Group Type OTHER

Smoking cessation counseling (Quitline)

Intervention Type BEHAVIORAL

Quitline offers community-based counseling session with a cessation counselor.

Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

Intervention Type BEHAVIORAL

Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.

Financial incentives for smoking cessation

Intervention Type BEHAVIORAL

Participants will receive financial incentives for bioconfirmed smoking cessation.

Enhanced Usual Care

Group Type OTHER

Smoking cessation counseling (Quitline)

Intervention Type BEHAVIORAL

Quitline offers community-based counseling session with a cessation counselor.

Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

Intervention Type BEHAVIORAL

Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smoking cessation counseling (Quitline)

Quitline offers community-based counseling session with a cessation counselor.

Intervention Type BEHAVIORAL

Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.

Intervention Type BEHAVIORAL

Financial incentives for smoking cessation

Participants will receive financial incentives for bioconfirmed smoking cessation.

Intervention Type BEHAVIORAL

Financial incentives for use of evidence-based smoking cessation therapies

Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. age ≥ 18 years
2. smoked tobacco during the prior 30 days,
3. have an active U.S. phone number and address,
4. can provide consent in English or Spanish and
5. are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit

Exclusion Criteria

1. use only smokeless tobacco,
2. are pregnant or breastfeeding,
3. are discharged to an institution (e.g., nursing home, long-term care facility),
4. are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soma Wali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph Ladapo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Scott Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

David Geffen School of Medicine

Los Angeles, California, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wali S, Gaitonde A, Sherman S, Min N, Pesantes A, Bidgoli A, Shirley A, Tseng CH, Ladapo J. Goal-directed versus outcome-based financial incentives for smoking cessation among low-income, hospitalised patients: rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) randomised controlled trial. BMJ Open. 2023 Sep 29;13(9):e074354. doi: 10.1136/bmjopen-2023-074354.

Reference Type DERIVED
PMID: 37775282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA045688-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Overcoming Nicotine Dependence to Enable Quitting
NCT05513872 RECRUITING PHASE1/PHASE2
Striving to Quit: First Breath
NCT01569490 COMPLETED NA