Smoking CessationFIESTA IINCT03979885
Financial Incentives for Smoking Treatment II
A study testing Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives for smoking cessation in people with Smoking Cessation and Tobacco Use Cessation, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Tobacco Use Cessation
- What is being tested?
- Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives for smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,058 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- smoked tobacco during the prior 30 days,
- have an active U.S. phone number and address,
- can provide consent in English or Spanish and
- are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit
Who cannot join
- use only smokeless tobacco,
- are pregnant or breastfeeding,
- are discharged to an institution (e.g., nursing home, long-term care facility),
- are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
David Geffen School of Medicine
Los Angeles, California, 90095
NYU Langone Health
New York, New York, 10016
About this study
Official title: Financial Incentives for Smoking Treatment
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.
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Being tested
- Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy), Financial incentives for smoking cessation, Financial incentives for use of evidence-based smoking cessation therapies
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counseling (Quitline)Behavioural
Quitline offers community-based counseling session with a cessation counselor.
Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)Behavioural
Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.
Financial incentives for smoking cessationBehavioural
Participants will receive financial incentives for bioconfirmed smoking cessation.
Financial incentives for use of evidence-based smoking cessation therapiesBehavioural
Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies
| Study group | Role | What they receive |
|---|---|---|
| Goal-Directed Incentives | Other | Not described Receives: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy); Behavioral: Financial incentives for use of evidence-based smoking cessation therapies |
| Outcome-Based Incentives | Other | Not described Receives: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy); Behavioral: Financial incentives for smoking cessation |
| Enhanced Usual Care | Other | Not described Receives: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence assessed by self-report and biochemically verified by salivary cotinine
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
Measured: 6 months
Secondary outcomes (4)
Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
Assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
Measured: 2 months
Quality of life as measured by PROMIS-29 Profile v2.0
Assessed by phone interviews.
Measured: 12 months
Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization
Measured: 12 months
Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start6 Jan 2020
- Primary completion7 Apr 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,058 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Olive View-UCLA Education & Research Institute
- Responsible party
- Principal investigator, Soma Wali, University of California, Los Angeles
- Investigators
- Joseph Ladapo, MD, PhD, Principal investigator, University of California, Los AngelesScott Sherman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979885
- Sponsor's protocol ID
- R01DA045688-01A1
- Acronym
- FIESTA II
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: UCLA is committed to the ideals of collaborative research and adheres to the sponsors Grant Policy on Sharing of Unique Research Resources. Requests for research resources generated as part of this project will be distributed in a timely manner. Publication of data shall occur during or at the end of the project, consistent with normal scientific practices. Research data that documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Data will be redacted to prevent the disclosure of personal identifiers.
Publications
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.
PubMed 37775282
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Smoking Treatment
- ClinicalTrials.gov ID
- NCT03979885
- Acronym / sponsor ID
- FIESTA II / R01DA045688-01A1
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,058 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- NYU Langone Health, Olive View-UCLA Education & Research Institute
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Goal-Directed Incentives | Other | Behavioral: Smoking cessation counseling (Quitline), Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy), Behavioral: Financial incentives for use of evidence-based smoking cessation therapies |
| Outcome-Based Incentives | Other | Behavioral: Smoking cessation counseling (Quitline), Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy), Behavioral: Financial incentives for smoking cessation |
| Enhanced Usual Care | Other | Behavioral: Smoking cessation counseling (Quitline), Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years
- smoked tobacco during the prior 30 days,
- have an active U.S. phone number and address,
- can provide consent in English or Spanish and
- are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit
Key exclusion criteria (4 listed)
- use only smokeless tobacco,
- are pregnant or breastfeeding,
- are discharged to an institution (e.g., nursing home, long-term care facility),
- are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counseling (Quitline)Quitline offers community-based counseling session with a cessation counselor. | Behavioural | Enhanced Usual Care, Goal-Directed Incentives, Outcome-Based Incentives |
| 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. | Behavioural | Enhanced Usual Care, Goal-Directed Incentives, Outcome-Based Incentives |
| Financial incentives for smoking cessationParticipants will receive financial incentives for bioconfirmed smoking cessation. | Behavioural | Outcome-Based Incentives |
| Financial incentives for use of evidence-based smoking cessation therapiesParticipants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies | Behavioural | Goal-Directed Incentives |
Primary outcome
Smoking abstinence assessed by self-report and biochemically verified by salivary cotinine
Time frame: 6 months
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
4 secondary outcomes
Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
Time frame: 2 months
Quality of life as measured by PROMIS-29 Profile v2.0
Time frame: 12 months
Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Time frame: 12 months
Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 37775282Wali 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.
- Individual participant dataSharing planned: Yes. UCLA is committed to the ideals of collaborative research and adheres to the sponsors Grant Policy on Sharing of Unique Research Resources. Requests for research resources generated as part of this project will be distributed in a timely manner. Publication of data shall occur during or at the end of the project, consistent with normal scientific practices. Research data that documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Data will be redacted to prevent the disclosure of personal identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ladapo, MD, PhD principal investigator
University of California, Los Angeles
Scott Sherman, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives for smoking cessation in people with Smoking Cessation and Tobacco Use Cessation, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence assessed by self-report and biochemically verified by salivary cotinine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.