Tobacco SmokingNCT04445662
Financial Incentives for Homeless Smokers: A Community-based RCT
A study testing Financial incentives, Varenicline and Tobacco coaching in people with Tobacco Smoking, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This community-based randomized controlled trial will test the effect of contingent financial rewards on smoking abstinence among homeless-experienced adult cigarette smokers. Participants will be recruited from 3 Boston Health Care for the Homeless Program locations: a shelter clinic, a day center clinic, and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Financial incentives, Varenicline and Tobacco coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 old
- Lifetime smoker of ≥100 cigarettes with current daily smoking of ≥5 cigarettes per day, verified by a saliva cotinine level of ≥30 ng/mL
- Ready to try quitting smoking within the next 3 months
- Proficient in English
- Currently or formerly homeless
- Have a primary care provider within BHCHP system
Who cannot join
- Unable to provide informed consent
- History of allergic reaction to varenicline
- Currently pregnant, planning to become pregnant, or breastfeeding
- Past-month suicidal ideation with plan or intent, or past 12-month history of suicidal behaviors or attempts
- Psychiatric hospitalization in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Health Care for the Homeless Program
Boston, Massachusetts, 02118
About this study
This community-based randomized controlled trial will test the effect of contingent financial rewards on smoking abstinence among homeless-experienced adult cigarette smokers. Participants will be recruited from 3 Boston Health Care for the Homeless Program locations: a shelter clinic, a day center clinic, and a medical center clinic. All participants will be offered a varenicline prescription and tobacco coaching. Incentive arm participants will receive escalating financial rewards for saliva cotinine levels <30 ng/ml, assessed 10 times over 12 weeks. Embedded qualitative interviews will explore the mechanisms of on-treatment and post-treatment effects of financial incentives on smoking abstinence in the context of homelessness.
Read the detailed description
People experiencing homelessness have a 3.5-fold higher prevalence of cigarette smoking in comparison to non-homeless people, contributing to 2-fold higher rates of lung cancer and 3- to 5-fold higher rates of tobacco-attributable death. Homeless smokers want to quit, but studies have not yet uncovered the optimal approach to help them do so. In an 8-week pilot randomized controlled trial (RCT) at Boston Health Care for the Homeless Program (BHCHP), we found that financial incentives for smoking abstinence were associated with 7-fold higher odds of brief smoking abstinence in comparison to a non-incentivized control condition. These results suggest that financial incentives are a promising approach for reducing smoking in this vulnerable population, but further investigation in a larger sample is needed to improve the duration of on-treatment abstinence, assess post-treatment effects, and better understand mechanisms of action and contextual factors that may influence treatment response.
To address the above gaps in evidence, we will conduct a community-based RCT of financial incentives for smoking abstinence among adult smokers at BHCHP. Recognized as a leader in homeless health care, BHCHP serves 12,000 currently and formerly homeless patients annually throughout greater Boston. We will randomize 180 participants recruited from 3 BHCHP sites: a shelter clinic, a day center clinic, and a medical center clinic. All participants will be offered 12 weeks of varenicline, 5 sessions of tobacco coaching, and 10 cotinine monitoring visits over a 12-week period. Participants randomized to the financial incentives arm (n=90) will receive escalating debit card payments (range $25-$70) at each monitoring visit for saliva cotinine levels <30 ng/ml. Control arm participants (n=90) will receive a fixed payment ($10) at each monitoring visit regardless of their saliva cotinine level. We will use an embedded-experiment mixed methods design, where qualitative ('qual') data collection is embedded within a larger quantitative ('QUAN') RCT with the following specific aims:
Aim 1. (QUAN) To determine the effect of the financial incentives intervention on cotinine-verified 7-day smoking abstinence at A) the end of treatment (12 weeks) and B) 12 weeks after treatment (24 weeks).
Hypotheses: Incentive arm participants will have significantly greater cotinine-verified 7-day smoking abstinence than control arm participants at A) 12 weeks and B) 24 weeks.
Aim 2. (qual) To assess why, how, and under what circumstances homeless smokers A) achieve abstinence in response to financial incentives and B) maintain abstinence after incentives are stopped.
Interviews with participants at A) 12 weeks (N=30) and B) 24 weeks (N=20) will examine cognitive ('why?'), procedural ('how?'), and contextual ('under what circumstances?') dimensions of their response to financial incentives to generate hypotheses about potential mechanisms for on-treatment and post-treatment effects and to inform modifications of the intervention for future use.
- Conditions
- Tobacco Smoking
- Being tested
- Financial incentives, Varenicline, Tobacco coaching
- Keywords
- Smoking Cessation, Homelessness, Financial Incentives
- Medical subject headings
- Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentivesBehavioural
Also called Contingency management
Escalating financial rewards for saliva cotinine levels <30 ng/mL, assessed 10 times over 12 weeks
VareniclineDrug
Also called Chantix
- Day 1 - 3: 0.5 mg daily
- Day 4 - 7: 0.5 mg twice daily
- Day 8 - Week 12: 1 mg twice daily
- Dose/schedule may be adjusted based on medical history and clinician judgement
Tobacco coachingBehavioural
Also called Smoking cessation counseling
5 one-on-one tobacco cessation coaching sessions over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control (n=90) | Active comparator | * Varenicline
* Tobacco coaching
* Saliva cotinine monitoring with fixed payments ($10) regardless of results Receives: Drug: Varenicline; Behavioral: Tobacco coaching |
| Financial incentives (n=90) | Experimental | * Varenicline
* Tobacco coaching
* Saliva cotinine monitoring with escalating payments ($25-70) for levels <30 ng/ml Receives: Behavioral: Financial incentives; Drug: Varenicline; Behavioral: Tobacco coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cotinine-verified 7-day Smoking Abstinence at 12 Weeks
Point-prevalent smoking abstinence, defined as self-report of not smoking in the past 7 days and verified by a salivary cotinine level <10 ng/ml.
Measured: 12 weeks
Secondary outcomes (1)
Cotinine-verified 7-day Smoking Abstinence at 24 Weeks
Point-prevalent smoking abstinence, defined as self-report of not smoking in the past 7 days and verified by a salivary cotinine level <10 ng/ml.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start10 Jun 2021
- Primary completion1 Aug 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Travis Paul Baggett, Massachusetts General Hospital
- Investigators
- Travis Baggett, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445662
- Sponsor's protocol ID
- 2019P000034
- Other IDs
- R01CA235617-01
- Status last verified
- Oct 2025
- First submitted
- 22 Jun 2020
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the data and personal health information involved, we do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Homeless Smokers: A Community-based RCT
- ClinicalTrials.gov ID
- NCT04445662
- Acronym / sponsor ID
- 2019P000034
- Conditions
- Tobacco Smoking
- Keywords
- Smoking Cessation, Homelessness, Financial Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This community-based randomized controlled trial will test the effect of contingent financial rewards on smoking abstinence among homeless-experienced adult cigarette smokers. Participants will be recruited from 3 Boston Health Care for the Homeless Program locations: a shelter clinic, a day center clinic, and a medical center clinic. All participants will be offered a varenicline prescription and tobacco coaching. Incentive arm participants will receive escalating financial rewards for saliva cotinine levels <30 ng/ml, assessed 10 times over 12 weeks. Embedded qualitative interviews will explore the mechanisms of on-treatment and post-treatment effects of financial incentives on smoking abstinence in the context of homelessness.
Detailed description
People experiencing homelessness have a 3.5-fold higher prevalence of cigarette smoking in comparison to non-homeless people, contributing to 2-fold higher rates of lung cancer and 3- to 5-fold higher rates of tobacco-attributable death. Homeless smokers want to quit, but studies have not yet uncovered the optimal approach to help them do so. In an 8-week pilot randomized controlled trial (RCT) at Boston Health Care for the Homeless Program (BHCHP), we found that financial incentives for smoking abstinence were associated with 7-fold higher odds of brief smoking abstinence in comparison to a non-incentivized control condition. These results suggest that financial incentives are a promising approach for reducing smoking in this vulnerable population, but further investigation in a larger sample is needed to improve the duration of on-treatment abstinence, assess post-treatment effects, and better understand mechanisms of action and contextual factors that may influence treatment response.
To address the above gaps in evidence, we will conduct a community-based RCT of financial incentives for smoking abstinence among adult smokers at BHCHP. Recognized as a leader in homeless health care, BHCHP serves 12,000 currently and formerly homeless patients annually throughout greater Boston. We will randomize 180 participants recruited from 3 BHCHP sites: a shelter clinic, a day center clinic, and a medical center clinic. All participants will be offered 12 weeks of varenicline, 5 sessions of tobacco coaching, and 10 cotinine monitoring visits over a 12-week period. Participants randomized to the financial incentives arm (n=90) will receive escalating debit card payments (range $25-$70) at each monitoring visit for saliva cotinine levels <30 ng/ml. Control arm participants (n=90) will receive a fixed payment ($10) at each monitoring visit regardless of their saliva cotinine level. We will use an embedded-experiment mixed methods design, where qualitative ('qual') data collection is embedded within a larger quantitative ('QUAN') RCT with the following specific aims:
Aim 1. (QUAN) To determine the effect of the financial incentives intervention on cotinine-verified 7-day smoking abstinence at A) the end of treatment (12 weeks) and B) 12 weeks after treatment (24 weeks).
Hypotheses: Incentive arm participants will have significantly greater cotinine-verified 7-day smoking abstinence than control arm participants at A) 12 weeks and B) 24 weeks.
Aim 2. (qual) To assess why, how, and under what circumstances homeless smokers A) achieve abstinence in response to financial incentives and B) maintain abstinence after incentives are stopped.
Interviews with participants at A) 12 weeks (N=30) and B) 24 weeks (N=20) will examine cognitive ('why?'), procedural ('how?'), and contextual ('under what circumstances?') dimensions of their response to financial incentives to generate hypotheses about potential mechanisms for on-treatment and post-treatment effects and to inform modifications of the intervention for future use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (n=90) | Active comparator | Drug: Varenicline, Behavioral: Tobacco coaching* Varenicline * Tobacco coaching * Saliva cotinine monitoring with fixed payments ($10) regardless of results |
| Financial incentives (n=90) | Experimental | Behavioral: Financial incentives, Drug: Varenicline, Behavioral: Tobacco coaching* Varenicline * Tobacco coaching * Saliva cotinine monitoring with escalating payments ($25-70) for levels <30 ng/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old
- Lifetime smoker of ≥100 cigarettes with current daily smoking of ≥5 cigarettes per day, verified by a saliva cotinine level of ≥30 ng/mL
- Ready to try quitting smoking within the next 3 months
- Proficient in English
- Currently or formerly homeless
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- History of allergic reaction to varenicline
- Currently pregnant, planning to become pregnant, or breastfeeding
- Past-month suicidal ideation with plan or intent, or past 12-month history of suicidal behaviors or attempts
- Psychiatric hospitalization in the past 3 months
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 |
|---|---|---|
| Financial incentivesAlso: Contingency managementEscalating financial rewards for saliva cotinine levels <30 ng/mL, assessed 10 times over 12 weeks | Behavioural | Financial incentives (n=90) |
| VareniclineAlso: Chantix* Day 1 - 3: 0.5 mg daily * Day 4 - 7: 0.5 mg twice daily * Day 8 - Week 12: 1 mg twice daily * Dose/schedule may be adjusted based on medical history and clinician judgement | Drug | Control (n=90), Financial incentives (n=90) |
| Tobacco coachingAlso: Smoking cessation counseling5 one-on-one tobacco cessation coaching sessions over 12 weeks | Behavioural | Control (n=90), Financial incentives (n=90) |
Primary outcome
Cotinine-verified 7-day Smoking Abstinence at 12 Weeks
Time frame: 12 weeks
Point-prevalent smoking abstinence, defined as self-report of not smoking in the past 7 days and verified by a salivary cotinine level <10 ng/ml.
1 secondary outcome
Cotinine-verified 7-day Smoking Abstinence at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data and personal health information involved, we do not plan to share IPD.
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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.
Travis Baggett, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives, Varenicline and Tobacco coaching in people with Tobacco Smoking, run by Massachusetts General Hospital at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cotinine-verified 7-day Smoking Abstinence at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2025.