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Financial Incentives for Homeless Smokers: A Community-based RCT

Financial Incentives for Homeless Smokers: A Community-based RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04445662
Enrollment
184
Registered
2020-06-24
Start date
2021-06-10
Completion date
2024-10-24
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Smoking

Keywords

Smoking Cessation, Homelessness, Financial Incentives

Brief 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 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.

Interventions

BEHAVIORALFinancial incentives

Escalating financial rewards for saliva cotinine levels \<30 ng/mL, assessed 10 times over 12 weeks

DRUGVarenicline

* 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

BEHAVIORALTobacco coaching

5 one-on-one tobacco cessation coaching sessions over 12 weeks

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Cotinine-verified 7-day Smoking Abstinence at 12 Weeks12 weeksPoint-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.

Secondary

MeasureTime frameDescription
Cotinine-verified 7-day Smoking Abstinence at 24 Weeks24 weeksPoint-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.

Countries

United States

Participant flow

Recruitment details

Recruitment took place between 2021-2024 at Boston Health Care for the Homeless Program (BHCHP), a federally funded Health Care for the Homeless (HCH) organization. Participants were recruited via in-person outreach at BHCHP clinic sites, telephone outreach to BHCHP patients with a past-year clinical encounter and electronic health record (EHR) documentation of current smoking, self-referrals in response to flyers or word of mouth, and referrals from BHCHP clinicians.

Pre-assignment details

Enrolled participants provided written informed consent and completed a staff-administered baseline survey. To be assigned a study arm, enrolled participants were asked to attend a randomization appointment within 4 weeks of enrollment.

Participants by arm

ArmCount
Control (n=68)
* Varenicline * Tobacco coaching * Saliva cotinine monitoring with fixed payments ($10) regardless of results Varenicline: - 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 coaching: 5 one-on-one tobacco cessation coaching sessions over 12 weeks
68
Financial incentives (n=69)
* Varenicline * Tobacco coaching * Saliva cotinine monitoring with escalating payments ($25-70) for levels \<30 ng/ml Financial incentives: Escalating financial rewards for saliva cotinine levels \<30 ng/mL, assessed 10 times over 12 weeks Varenicline: - 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 coaching: 5 one-on-one tobacco cessation coaching sessions over 12 weeks
69
Total137

Withdrawals & dropouts

PeriodReasonFG000FG001
On treatment (0-12 weeks)Deemed ineligible after randomization due to non-smoking status10
On treatment (0-12 weeks)Withdrawal by Subject25
On treatment (0-12 weeks)Withdrawn by PI due to behavioral concerns10
Post-treatment (12-24 weeks)Death10

Baseline characteristics

CharacteristicControl (n=68)TotalFinancial incentives (n=69)
Age, Continuous51.2 years
STANDARD_DEVIATION 10.3
50.1 years
STANDARD_DEVIATION 10.2
49.0 years
STANDARD_DEVIATION 10.1
Alcohol use disorder18 Participants27 Participants9 Participants
Cigarettes per day14.3 cigarettes
STANDARD_DEVIATION 6.8
14.2 cigarettes
STANDARD_DEVIATION 7
14.1 cigarettes
STANDARD_DEVIATION 7.3
Drug use disorder40 Participants79 Participants39 Participants
Homelessness status
Currently homeless
36 Participants71 Participants35 Participants
Homelessness status
Formerly homeless
32 Participants66 Participants34 Participants
Moderate/severe anxiety28 Participants52 Participants24 Participants
Moderate/severe depression25 Participants52 Participants27 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic/Latine
6 Participants23 Participants17 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Non-Hispanic Black
17 Participants31 Participants14 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Non-Hispanic Other
11 Participants21 Participants10 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Non-Hispanic White
34 Participants60 Participants26 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Unknown
0 Participants2 Participants2 Participants
Sex/Gender, Customized
Gender
Female
24 Participants35 Participants11 Participants
Sex/Gender, Customized
Gender
Male
44 Participants100 Participants56 Participants
Sex/Gender, Customized
Gender
Other
0 Participants2 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 690 / 69
other
Total, other adverse events
43 / 6937 / 69
serious
Total, serious adverse events
3 / 692 / 69

Outcome results

Primary

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.

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control (n=68)Cotinine-verified 7-day Smoking Abstinence at 12 Weeks3 Participants
Financial incentives (n=69)Cotinine-verified 7-day Smoking Abstinence at 12 Weeks4 Participants
p-value: 0.71Chi-squared
Secondary

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.

Time frame: 24 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control (n=68)Cotinine-verified 7-day Smoking Abstinence at 24 Weeks3 Participants
Financial incentives (n=69)Cotinine-verified 7-day Smoking Abstinence at 24 Weeks5 Participants
p-value: 0.48Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026