<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/NCT03799315</url>
  </required_header>
  <id_info>
    <org_study_id>RC-2018-0013</org_study_id>
    <nct_id>NCT03799315</nct_id>
  </id_info>
  <brief_title>Jail-Based Use of Smoking Cessation Treatment Study</brief_title>
  <acronym>JUST</acronym>
  <official_title>Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hennepin Healthcare Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hennepin County Adult Detention Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hennepin Healthcare Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking rates remain above 60% for individuals involved in the criminal justice system and&#xD;
      contribute to elevated mortality rates in this population. Addressing smoking disparities&#xD;
      among justice-involved individuals is a critical public health issue in Minnesota, one of a&#xD;
      few states with rising incarceration rates. People who are incarcerated represent the&#xD;
      intersection of multiple high-priority populations (disproportionately African-American,&#xD;
      Native American, low-income, homeless, on Medicaid, and suffering from mental illness and&#xD;
      substance use disorders). This study examines the impact of a smoking cessation intervention&#xD;
      for individuals discharged from jail to the community on smoking abstinence. Participants&#xD;
      will be randomized to either 1) guideline-based, in-person smoking cessation counseling&#xD;
      during incarceration, telephone counseling after incarceration, and nicotine replacement, or&#xD;
      2) enhanced treatment as usual. This study's findings will be used to develop a larger,&#xD;
      multi-site study that is fully powered to measure longer-term health and smoking cessation&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post&#xD;
      discharge from jail. During these assessments, seven-day point prevalence abstinence will be&#xD;
      bio-verified with exhaled carbon monoxide, and self-reported general health, physical health,&#xD;
      mental health, and substance use measures will also be obtained. The analysis is fully&#xD;
      powered (i.e., power &gt; .8) to detect significant between group effects on the primary outcome&#xD;
      (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence&#xD;
      abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to&#xD;
      treat sample and will utilize pre-specified logistic and linear regression models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">August 29, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioverified 7-day point prevalence abstinence from smoking</measure>
    <time_frame>Over 3 weeks</time_frame>
    <description>Bioverified 7-day point prevalence abstinence from smoking</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Lapse</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>Days to first lapse (i.e., any cigarette use, even a puff)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Relapse</measure>
    <time_frame>3 weeks, 12 weeks</time_frame>
    <description>Days to first relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bio-verified 7-day point prevalence abstinence from smoking</measure>
    <time_frame>Over 12 weeks</time_frame>
    <description>Bioverified 7-day point prevalence abstinence from smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Affect</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>Self-reported hospitalizations and use of the emergency department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse</measure>
    <time_frame>1 week, 3 weeks, 12 weeks</time_frame>
    <description>Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Jail-Based Use of Smoking Cessation Treatment (JUST)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Treatment As Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Replacement Therapy</intervention_name>
    <description>All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.</description>
    <arm_group_label>Jail-Based Use of Smoking Cessation Treatment (JUST)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.</description>
    <arm_group_label>Jail-Based Use of Smoking Cessation Treatment (JUST)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use of ≥ 1 cigarette per day prior to incarceration&#xD;
&#xD;
          -  Expected release from the Hennepin Adult Detention Center to the community within 90&#xD;
             days&#xD;
&#xD;
          -  Age 18-64&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  Lives within 20 minutes of Hennepin County Medical Center and has no plans to move&#xD;
             away from area for 4 months&#xD;
&#xD;
          -  Willing to attempt quitting or reducing smoking at discharge&#xD;
&#xD;
          -  Has a telephone&#xD;
&#xD;
          -  Cleared for nicotine lozenge safety by jail health care provider and willing to use at&#xD;
             discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Current mental health crisis (i.e., currently experiencing significant mania,&#xD;
             psychosis, or suicidality)&#xD;
&#xD;
          -  Unable to ambulate independently&#xD;
&#xD;
          -  Acute medical condition that would impair participant's ability to follow-up for&#xD;
             assessments&#xD;
&#xD;
          -  Expected discharge to a control institutional setting (e.g., locked state mental&#xD;
             health facility or prison)&#xD;
&#xD;
          -  Active pregnancy&#xD;
&#xD;
          -  Heart attack within the last two weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hennepin Healthcare Research Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2.</citation>
    <PMID>27832052</PMID>
  </reference>
  <reference>
    <citation>Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y.</citation>
    <PMID>30635028</PMID>
  </reference>
  <reference>
    <citation>Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23.</citation>
    <PMID>28116579</PMID>
  </reference>
  <reference>
    <citation>Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542.</citation>
    <PMID>25097186</PMID>
  </reference>
  <reference>
    <citation>Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.</citation>
  </reference>
  <reference>
    <citation>Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5.</citation>
    <PMID>27638837</PMID>
  </reference>
  <reference>
    <citation>Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21.</citation>
    <PMID>28323472</PMID>
  </reference>
  <reference>
    <citation>Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991.</citation>
    <PMID>29309230</PMID>
  </reference>
  <reference>
    <citation>Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10.</citation>
    <PMID>24817280</PMID>
  </reference>
  <reference>
    <citation>Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767.</citation>
    <PMID>21974746</PMID>
  </reference>
  <reference>
    <citation>Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197.</citation>
    <PMID>23567902</PMID>
  </reference>
  <reference>
    <citation>Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941.</citation>
    <PMID>11716663</PMID>
  </reference>
  <reference>
    <citation>Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2.</citation>
    <PMID>22160762</PMID>
  </reference>
  <reference>
    <citation>Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9.</citation>
    <PMID>12915172</PMID>
  </reference>
  <reference>
    <citation>Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11.</citation>
    <PMID>26069036</PMID>
  </reference>
  <reference>
    <citation>Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.</citation>
    <PMID>28415979</PMID>
  </reference>
  <reference>
    <citation>A randomised controlled study of the Health Intervention &quot;SNAP&quot; in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017.</citation>
  </reference>
  <reference>
    <citation>de Andrade D, Kinner SA. Systematic review of health and behavioural outcomes of smoking cessation interventions in prisons. Tob Control. 2016 Sep;26(5):495-501. doi: 10.1136/tobaccocontrol-2016-053297. Epub 2016 Oct 18.</citation>
    <PMID>27798322</PMID>
  </reference>
  <reference>
    <citation>Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017.</citation>
  </reference>
  <reference>
    <citation>Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017.</citation>
  </reference>
  <reference>
    <citation>Binswanger IA, Nowels C, Corsi KF, Long J, Booth RE, Kutner J, Steiner JF. &quot;From the prison door right to the sidewalk, everything went downhill,&quot; a qualitative study of the health experiences of recently released inmates. Int J Law Psychiatry. 2011 Jul-Aug;34(4):249-55. doi: 10.1016/j.ijlp.2011.07.002. Epub 2011 Jul 29.</citation>
    <PMID>21802731</PMID>
  </reference>
  <reference>
    <citation>Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1.</citation>
    <PMID>18381994</PMID>
  </reference>
  <reference>
    <citation>Wang EA, Green J. Incarceration as a key variable in racial disparities of asthma prevalence. BMC Public Health. 2010 May 28;10:290. doi: 10.1186/1471-2458-10-290.</citation>
    <PMID>20509891</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hennepin Healthcare Research Institute</investigator_affiliation>
    <investigator_full_name>Tyler Winkelman</investigator_full_name>
    <investigator_title>Clinician-Investigator</investigator_title>
  </responsible_party>
  <keyword>Incarceration</keyword>
  <keyword>Smoking</keyword>
  <keyword>Counseling</keyword>
  <keyword>Nicotine Replacement</keyword>
  <keyword>Disparities</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03799315
org study id: RC-2018-0013
nct id: NCT03799315
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Smoking rates remain above 60% for individuals involved in the criminal justice system and
      contribute to elevated mortality rates in this population. Addressing smoking disparities
      among justice-involved individuals is a critical public health issue in Minnesota, one of a
      few states with rising incarceration rates. People who are incarcerated represent the
      intersection of multiple high-priority populations (disproportionately African-American,
      Native American, low-income, homeless, on Medicaid, and suffering from mental illness and
      substance use disorders). This study examines the impact of a smoking cessation intervention
      for individuals discharged from jail to the community on smoking abstinence. Participants
      will be randomized to either 1) guideline-based, in-person smoking cessation counseling
      during incarceration, telephone counseling after incarceration, and nicotine replacement, or
      2) enhanced treatment as usual. This study's findings will be used to develop a larger,
      multi-site study that is fully powered to measure longer-term health and smoking cessation
      outcomes.
Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post
      discharge from jail. During these assessments, seven-day point prevalence abstinence will be
      bio-verified with exhaled carbon monoxide, and self-reported general health, physical health,
      mental health, and substance use measures will also be obtained. The analysis is fully
      powered (i.e., power > .8) to detect significant between group effects on the primary outcome
      (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence
      abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to
      treat sample and will utilize pre-specified logistic and linear regression models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bioverified 7-day point prevalence abstinence from smoking
time frame: Over 3 weeks
description: Bioverified 7-day point prevalence abstinence from smoking
measure: Time to Lapse
time frame: 1 week, 3 weeks, 12 weeks
description: Days to first lapse (i.e., any cigarette use, even a puff)
measure: Time to Relapse
time frame: 3 weeks, 12 weeks
description: Days to first relapse
measure: Bio-verified 7-day point prevalence abstinence from smoking
time frame: Over 12 weeks
description: Bioverified 7-day point prevalence abstinence from smoking
measure: Health-related quality of life
time frame: 1 week, 3 weeks, 12 weeks
description: Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.
measure: Depressive symptoms
time frame: 1 week, 3 weeks, 12 weeks
description: The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.
measure: Self-Reported Affect
time frame: 1 week, 3 weeks, 12 weeks
description: 10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.
measure: Health care utilization
time frame: 1 week, 3 weeks, 12 weeks
description: Self-reported hospitalizations and use of the emergency department
measure: Substance abuse
time frame: 1 week, 3 weeks, 12 weeks
description: Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.
arm group label: Jail-Based Use of Smoking Cessation Treatment (JUST)
arm group type: Experimental
description: Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail.
arm group label: Enhanced Treatment As Usual (TAU)
arm group type: No Intervention
description: Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking.
intervention type: Drug
intervention name: Nicotine Replacement Therapy
description: All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.
arm group label: Jail-Based Use of Smoking Cessation Treatment (JUST)
intervention type: Behavioral
intervention name: Counseling
description: All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.
arm group label: Jail-Based Use of Smoking Cessation Treatment (JUST)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2.
PMID: 27832052
citation: Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y.
PMID: 30635028
citation: Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23.
PMID: 28116579
citation: Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542.
PMID: 25097186
citation: Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.
citation: Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5.
PMID: 27638837
citation: Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21.
PMID: 28323472
citation: Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991.
PMID: 29309230
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responsible party type: Principal Investigator
investigator affiliation: Hennepin Healthcare Research Institute
investigator full name: Tyler Winkelman
investigator title: Clinician-Investigator
mesh term: Nicotine
sharing ipd: Undecided