<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/NCT02968095</url>
  </required_header>
  <id_info>
    <org_study_id>K23DA037320</org_study_id>
    <secondary_id>K23DA037320</secondary_id>
    <nct_id>NCT02968095</nct_id>
  </id_info>
  <brief_title>Text Message Support to Prevent Smoking Relapse</brief_title>
  <official_title>Text Message Support to Prevent Smoking Relapse in Community Treatment Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miami University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Miami University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to test a text message intervention for people who are&#xD;
      beginning an attempt to quit smoking. The intervention seeks to teach people to think about&#xD;
      their cravings to smoke in more helpful ways. The investigators expect that participants&#xD;
      receiving the text message craving program will be less likely to begin smoking again&#xD;
      compared to participants in a control condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Actual">August 23, 2019</completion_date>
  <primary_completion_date type="Actual">August 23, 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>7-Day Point Prevalence Abstinence</measure>
    <time_frame>End of Treatment (6-week) Follow-Up</time_frame>
    <description>Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Text Message Craving Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Help Manual Plus Control Texts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A print, self-help manual plus general motivational text messages delivered 2-3 times per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Message Craving Program</intervention_name>
    <description>Text messages targeting cravings delivered 2-3 times per day.</description>
    <arm_group_label>Text Message Craving Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Help Manual Plus Control Texts</intervention_name>
    <description>Self-help manual plus motivational text messages delivered 2-3 times per day.</description>
    <arm_group_label>Self-Help Manual Plus Control Texts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for&#xD;
             at least 3 months. During the first visit smoking status will be verified by a Carbon&#xD;
             Monoxide level of at least 8 parts per million.&#xD;
&#xD;
          -  Have a mobile phone and use text messaging at least monthly&#xD;
&#xD;
          -  Be planning to quit smoking without pharmacological help.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairment&#xD;
&#xD;
          -  Current therapy or pharmacological intervention for smoking or nicotine cravings&#xD;
&#xD;
          -  Inability to read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Miami University</name>
      <address>
        <city>Oxford</city>
        <state>Ohio</state>
        <zip>45056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 13, 2019</last_update_submitted>
  <last_update_submitted_qc>November 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</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>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02968095
org study id: K23DA037320
secondary id: K23DA037320
nct id: NCT02968095
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to test a text message intervention for people who are
      beginning an attempt to quit smoking. The intervention seeks to teach people to think about
      their cravings to smoke in more helpful ways. The investigators expect that participants
      receiving the text message craving program will be less likely to begin smoking again
      compared to participants in a control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 7-Day Point Prevalence Abstinence
time frame: End of Treatment (6-week) Follow-Up
description: Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking.
arm group label: Text Message Craving Program
arm group type: Experimental
description: Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.
arm group label: Self-Help Manual Plus Control Texts
arm group type: Active Comparator
description: A print, self-help manual plus general motivational text messages delivered 2-3 times per day.
intervention type: Behavioral
intervention name: Text Message Craving Program
description: Text messages targeting cravings delivered 2-3 times per day.
arm group label: Text Message Craving Program
intervention type: Behavioral
intervention name: Self-Help Manual Plus Control Texts
description: Self-help manual plus motivational text messages delivered 2-3 times per day.
arm group label: Self-Help Manual Plus Control Texts
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: No