- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04445662
Financial Incentives for Homeless Smokers: A Community-based RCT
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Travis Baggett, MD
- Phone Number: 617-643-9314
- Email: TBAGGETT@mgh.harvard.edu
Study Contact Backup
- Name: Nora Sporn, MPH
- Phone Number: 617-320-4307
- Email: nsporn@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston Health Care for the Homeless Program
-
Contact:
- Nora Sporn, MPH
- Phone Number: 617-320-4307
- Email: nsporn@partners.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control (n=90)
|
Other Names:
5 one-on-one tobacco cessation coaching sessions over 12 weeks
Other Names:
|
Experimental: Financial incentives (n=90)
|
Other Names:
5 one-on-one tobacco cessation coaching sessions over 12 weeks
Other Names:
Escalating financial rewards for saliva cotinine levels <30 ng/mL, assessed 10 times over 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cotinine-verified 7-day smoking abstinence at 24 weeks
Time Frame: 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.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Travis Baggett, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P000034
- R01CA235617-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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