<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445662</url>
  </required_header>
  <id_info>
    <org_study_id>2019P000034</org_study_id>
    <secondary_id>R01CA235617-01</secondary_id>
    <nct_id>NCT04445662</nct_id>
  </id_info>
  <brief_title>Financial Incentives for Homeless Smokers: A Community-based RCT</brief_title>
  <official_title>Financial Incentives for Homeless Smokers: A Community-based RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This community-based randomized controlled trial will test the effect of contingent financial&#xD;
      rewards on smoking abstinence among homeless-experienced adult cigarette smokers.&#xD;
      Participants will be recruited from 3 Boston Health Care for the Homeless Program locations:&#xD;
      a shelter clinic, a day center clinic, and a medical center clinic. All participants will be&#xD;
      offered a varenicline prescription and tobacco coaching. Incentive arm participants will&#xD;
      receive escalating financial rewards for saliva cotinine levels &lt;30 ng/ml, assessed 10 times&#xD;
      over 12 weeks. Embedded qualitative interviews will explore the mechanisms of on-treatment&#xD;
      and post-treatment effects of financial incentives on smoking abstinence in the context of&#xD;
      homelessness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People experiencing homelessness have a 3.5-fold higher prevalence of cigarette smoking in&#xD;
      comparison to non-homeless people, contributing to 2-fold higher rates of lung cancer and 3-&#xD;
      to 5-fold higher rates of tobacco-attributable death. Homeless smokers want to quit, but&#xD;
      studies have not yet uncovered the optimal approach to help them do so. In an 8-week pilot&#xD;
      randomized controlled trial (RCT) at Boston Health Care for the Homeless Program (BHCHP), we&#xD;
      found that financial incentives for smoking abstinence were associated with 7-fold higher&#xD;
      odds of brief smoking abstinence in comparison to a non-incentivized control condition. These&#xD;
      results suggest that financial incentives are a promising approach for reducing smoking in&#xD;
      this vulnerable population, but further investigation in a larger sample is needed to improve&#xD;
      the duration of on-treatment abstinence, assess post-treatment effects, and better understand&#xD;
      mechanisms of action and contextual factors that may influence treatment response.&#xD;
&#xD;
      To address the above gaps in evidence, we will conduct a community-based RCT of financial&#xD;
      incentives for smoking abstinence among adult smokers at BHCHP. Recognized as a leader in&#xD;
      homeless health care, BHCHP serves 12,000 currently and formerly homeless patients annually&#xD;
      throughout greater Boston. We will randomize 400 participants recruited from 3 BHCHP sites: a&#xD;
      shelter clinic, a day center clinic, and a medical center clinic. All participants will be&#xD;
      offered 12 weeks of varenicline, 5 sessions of tobacco coaching, and 10 cotinine monitoring&#xD;
      visits over a 12-week period. Participants randomized to the financial incentives arm (n=200)&#xD;
      will receive escalating debit card payments (range $25-$70) at each monitoring visit for&#xD;
      saliva cotinine levels &lt;30 ng/ml. Control arm participants (n=200) will receive a fixed&#xD;
      payment ($10) at each monitoring visit regardless of their saliva cotinine level. We will use&#xD;
      an embedded-experiment mixed methods design, where qualitative ('qual') data collection is&#xD;
      embedded within a larger quantitative ('QUAN') RCT with the following specific aims:&#xD;
&#xD;
      Aim 1. (QUAN) To determine the effect of the financial incentives intervention on&#xD;
      cotinine-verified 7-day smoking abstinence at A) the end of treatment (12 weeks) and B) 12&#xD;
      weeks after treatment (24 weeks).&#xD;
&#xD;
      Hypotheses: Incentive arm participants will have significantly greater cotinine-verified&#xD;
      7-day smoking abstinence than control arm participants at A) 12 weeks and B) 24 weeks.&#xD;
&#xD;
      Aim 2. (qual) To assess why, how, and under what circumstances homeless smokers A) achieve&#xD;
      abstinence in response to financial incentives and B) maintain abstinence after incentives&#xD;
      are stopped.&#xD;
&#xD;
      Interviews with participants at A) 12 weeks (N=30) and B) 24 weeks (N=20) will examine&#xD;
      cognitive ('why?'), procedural ('how?'), and contextual ('under what circumstances?')&#xD;
      dimensions of their response to financial incentives to generate hypotheses about potential&#xD;
      mechanisms for on-treatment and post-treatment effects and to inform modifications of the&#xD;
      intervention for future use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 10, 2021</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cotinine-verified 7-day smoking abstinence at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Point-prevalent smoking abstinence, defined as self-report of not smoking in the past 7 days and verified by a salivary cotinine level &lt;10 ng/ml.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cotinine-verified 7-day smoking abstinence at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>Point-prevalent smoking abstinence, defined as self-report of not smoking in the past 7 days and verified by a salivary cotinine level &lt;10 ng/ml.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Tobacco Smoking</condition>
  <arm_group>
    <arm_group_label>Control (n=200)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Varenicline&#xD;
Tobacco coaching&#xD;
Saliva cotinine monitoring with fixed payments ($10) regardless of results</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Financial incentives (n=200)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Varenicline&#xD;
Tobacco coaching&#xD;
Saliva cotinine monitoring with escalating payments ($25-70) for levels &lt;30 ng/ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial incentives</intervention_name>
    <description>Escalating financial rewards for saliva cotinine levels &lt;30 ng/mL, assessed 10 times over 12 weeks</description>
    <arm_group_label>Financial incentives (n=200)</arm_group_label>
    <other_name>Contingency management</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>Day 1 - 3: 0.5 mg daily&#xD;
Day 4 - 7: 0.5 mg twice daily&#xD;
Day 8 - Week 12: 1 mg twice daily&#xD;
Dose/schedule may be adjusted based on medical history and clinician judgement</description>
    <arm_group_label>Control (n=200)</arm_group_label>
    <arm_group_label>Financial incentives (n=200)</arm_group_label>
    <other_name>Chantix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tobacco coaching</intervention_name>
    <description>5 one-on-one tobacco cessation coaching sessions over 12 weeks</description>
    <arm_group_label>Control (n=200)</arm_group_label>
    <arm_group_label>Financial incentives (n=200)</arm_group_label>
    <other_name>Smoking cessation counseling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old&#xD;
&#xD;
          -  Lifetime smoker of ≥100 cigarettes with current daily smoking of ≥5 cigarettes per&#xD;
             day, verified by a saliva cotinine level of ≥30 ng/mL&#xD;
&#xD;
          -  Ready to try quitting smoking within the next 3 months&#xD;
&#xD;
          -  Proficient in English&#xD;
&#xD;
          -  Currently or formerly homeless&#xD;
&#xD;
          -  Have a primary care provider within BHCHP system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  History of allergic reaction to varenicline&#xD;
&#xD;
          -  Currently pregnant, planning to become pregnant, or breastfeeding&#xD;
&#xD;
          -  Past-month suicidal ideation with plan or intent, or past 12-month history of suicidal&#xD;
             behaviors or attempts&#xD;
&#xD;
          -  Psychiatric hospitalization in the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Travis Baggett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Travis Baggett, MD</last_name>
    <phone>617-643-9314</phone>
    <email>TBAGGETT@mgh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nora Sporn, MPH</last_name>
    <phone>617-320-4307</phone>
    <email>nsporn@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Health Care for the Homeless Program</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nora Sporn, MPH</last_name>
      <phone>617-320-4307</phone>
      <email>nsporn@partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Travis Paul Baggett</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Smoking Cessation</keyword>
  <keyword>Homelessness</keyword>
  <keyword>Financial Incentives</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varenicline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to the sensitive nature of the data and personal health information involved, we do not plan to share IPD.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445662
org study id: 2019P000034
secondary id: R01CA235617-01
nct id: NCT04445662
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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 400 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=200)
      will receive escalating debit card payments (range $25-$70) at each monitoring visit for
      saliva cotinine levels <30 ng/ml. Control arm participants (n=200) 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cotinine-verified 7-day smoking abstinence at 12 weeks
time frame: 12 weeks
description: 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.
measure: Cotinine-verified 7-day smoking abstinence at 24 weeks
time frame: 24 weeks
description: 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.
arm group label: Control (n=200)
arm group type: Active Comparator
description: Varenicline
Tobacco coaching
Saliva cotinine monitoring with fixed payments ($10) regardless of results
arm group label: Financial incentives (n=200)
arm group type: Experimental
description: Varenicline
Tobacco coaching
Saliva cotinine monitoring with escalating payments ($25-70) for levels <30 ng/ml
intervention type: Behavioral
intervention name: Financial incentives
description: Escalating financial rewards for saliva cotinine levels <30 ng/mL, assessed 10 times over 12 weeks
arm group label: Financial incentives (n=200)
other name: Contingency management
intervention type: Drug
intervention name: Varenicline
description: 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
arm group label: Control (n=200)
arm group label: Financial incentives (n=200)
other name: Chantix
intervention type: Behavioral
intervention name: Tobacco coaching
description: 5 one-on-one tobacco cessation coaching sessions over 12 weeks
arm group label: Control (n=200)
arm group label: Financial incentives (n=200)
other name: Smoking cessation counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Travis Baggett, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Travis Baggett, MD
phone: 617-643-9314
email: TBAGGETT@mgh.harvard.edu
last name: Nora Sporn, MPH
phone: 617-320-4307
email: nsporn@partners.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Travis Paul Baggett
investigator title: Assistant Professor of Medicine
mesh term: Varenicline
sharing ipd: No
ipd description: Due to the sensitive nature of the data and personal health information involved, we do not plan to share IPD.