<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/NCT03042650</url>
  </required_header>
  <id_info>
    <org_study_id>018-16-FB</org_study_id>
    <nct_id>NCT03042650</nct_id>
  </id_info>
  <brief_title>Intensive Referral to Reduce Smoking in Probationers</brief_title>
  <official_title>Intensive Referral to Reduce Smoking in Probationers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Intensive Referral Intervention increases&#xD;
      motivation to quit cigarette smoking and quitting-related behaviors in probationers and also&#xD;
      to determine if Intensive Referral Intervention improves short-term substance use outcomes in&#xD;
      probationers with substance use disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD)&#xD;
      and smoke cigarettes. One-half of probation officers will be trained in the Intensive&#xD;
      Referral Intervention (IRI) while one-half will deliver Standard Practice which is to&#xD;
      encourage support group attendance. Research staff will assess fidelity to the IRI in trained&#xD;
      probation officers. The investigators propose to enroll 150 probationers over a four month&#xD;
      period and complete 3 and 6-month follow-up interviews to assess smoking and substance use&#xD;
      measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</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>Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder</measure>
    <time_frame>6 Months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges</measure>
    <time_frame>6 Months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Substance Use Disorder</condition>
  <arm_group>
    <arm_group_label>Intensive Referral Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive Referral Intervention will by done by trained probation officers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Practice Facilitated Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Current Practice will be provided by untrained probation officers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Referral Intervention Group</intervention_name>
    <description>The Intensive Referral Intervention Group will review a series of pamphlets regarding participation in 12-step meetings as well as smoking cessation that will be presented in a group setting to probationers in 3 sessions.</description>
    <arm_group_label>Intensive Referral Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Practice Facilitated Group</intervention_name>
    <description>The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.</description>
    <arm_group_label>Standard Practice Facilitated Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CBR-MH Probationers in Douglas County, NE&#xD;
&#xD;
          -  SUD&#xD;
&#xD;
          -  daily cigarette smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under guardianship&#xD;
&#xD;
          -  unwilling to provide personal contact information&#xD;
&#xD;
          -  unable to pass Mini-Cog&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Grant</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNMC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>December 18, 2022</last_update_submitted>
  <last_update_submitted_qc>December 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_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/NCT03042650
org study id: 018-16-FB
nct id: NCT03042650
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if Intensive Referral Intervention increases
      motivation to quit cigarette smoking and quitting-related behaviors in probationers and also
      to determine if Intensive Referral Intervention improves short-term substance use outcomes in
      probationers with substance use disorder.
This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD)
      and smoke cigarettes. One-half of probation officers will be trained in the Intensive
      Referral Intervention (IRI) while one-half will deliver Standard Practice which is to
      encourage support group attendance. Research staff will assess fidelity to the IRI in trained
      probation officers. The investigators propose to enroll 150 probationers over a four month
      period and complete 3 and 6-month follow-up interviews to assess smoking and substance use
      measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence
time frame: 6 Months
measure: Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar
time frame: 6 Months
measure: Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder
time frame: 6 Months
measure: Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges
time frame: 6 Months
arm group label: Intensive Referral Intervention Group
arm group type: Experimental
description: Intensive Referral Intervention will by done by trained probation officers
arm group label: Standard Practice Facilitated Group
arm group type: Active Comparator
description: Standard Current Practice will be provided by untrained probation officers
intervention type: Behavioral
intervention name: Intensive Referral Intervention Group
description: The Intensive Referral Intervention Group will review a series of pamphlets regarding participation in 12-step meetings as well as smoking cessation that will be presented in a group setting to probationers in 3 sessions.
arm group label: Intensive Referral Intervention Group
intervention type: Behavioral
intervention name: Standard Practice Facilitated Group
description: The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.
arm group label: Standard Practice Facilitated Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Grant
role: Principal Investigator
affiliation: UNMC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Undecided