N/A
N=138
Financial Incentives for Homeless Smokers: A Community-based RCT
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT04445662 ↗Enrolled (actual)
138
Serious AEs
3.6%
Results posted
Oct 2025
Primary outcome: Primary: Cotinine-verified 7-day Smoking Abstinence at 12 Weeks — 3; 4 Participants — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Financial incentives (Behavioral); Varenicline (Drug); Tobacco coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cotinine-verified 7-day Smoking Abstinence at 12 Weeks |
3; 4 | 0.71 |
| SECONDARY Cotinine-verified 7-day Smoking Abstinence at 24 Weeks |
3; 5 | 0.48 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04445662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.