Financial Incentives for Homeless Smokers: A Community-based RCT

NCT04445662 | Completed Results DMC

• 2 other identifiers: 2019P000034R01CA235617-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking

Keywords

Smoking Cessation; Homelessness; Financial Incentives

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Cotinine-verified 7-day Smoking Abstinence at 24 Weeks

  24 weeks

Study Arms (2)

Control (n=90)

ACTIVE COMPARATOR

* Varenicline * Tobacco coaching * Saliva cotinine monitoring with fixed payments ($10) regardless of results

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

Behavioral: Financial incentives; Drug: Varenicline; Behavioral: Tobacco coaching

Interventions

Financial incentives BEHAVIORAL

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

Also known as: Contingency management

Financial incentives (n=90)

Varenicline DRUG

* 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

Also known as: Chantix

Control (n=90); Financial incentives (n=90)

Tobacco coaching BEHAVIORAL

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

Also known as: Smoking cessation counseling

Control (n=90); Financial incentives (n=90)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Boston Health Care for the Homeless Program

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Various limitations led to lower than anticipated enrollment and limited statistical power. The COVID-19 pandemic substantially delayed study launch. Shortly after the initial launch, recruitment was halted and delayed again due to the recall and global shortage of varenicline (the study medication). Reductions in foot traffic at recruitment sites (due to COVID-19 and fluctuating local patterns of and responses to homelessness) led to slower rates of recruitment once the study was relaunched.

Results Point of Contact

• Title: Travis P Baggett MD MPH
• Organization: Massachusetts General Hospital

tbaggett@mgh.harvard.edu

617-643-9314

Study Officials

• Travis Baggett, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: June 10, 2021
• Primary Completion: August 1, 2024
• Study Completion: October 24, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)