<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/NCT01689168</url>
  </required_header>
  <id_info>
    <org_study_id>ROSE004</org_study_id>
    <nct_id>NCT01689168</nct_id>
  </id_info>
  <brief_title>Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation</brief_title>
  <official_title>Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern California University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southern California University of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tobacco use is the number one killer of Americans today. Most current smokers have tried and&#xD;
      failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and&#xD;
      withdrawal from smoking can lead to physical symptoms such as irritability, anxiety,&#xD;
      nervousness, depression and insomnia.&#xD;
&#xD;
      This study will examine the effects of tobacco cessation counseling and chiropractic&#xD;
      treatments on smokers who desire to quit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding ran out&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</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>Tobacco cessation</measure>
    <time_frame>Smoking diary will be complete for 3 months</time_frame>
    <description>Has the subject quit smoking?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary cotinine</measure>
    <time_frame>Baseline, 14, 30, 60 and 90 days</time_frame>
    <description>An urinary test for nicotine metabolites</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline, 14, 30, 60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline, 14, 30, 60 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Counseling plus chiropractic adjustments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Counseling alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>Tobacco cessation counseling</description>
    <arm_group_label>Counseling alone</arm_group_label>
    <arm_group_label>Counseling plus chiropractic adjustments</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chiropractic adjustment</intervention_name>
    <description>Full spine high velocity, low amplitude manipulation of the spine</description>
    <arm_group_label>Counseling plus chiropractic adjustments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 yrs and above&#xD;
&#xD;
          -  Smokers with desire to quit smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received chiropractic treatment or other manipulative therapies within the last month&#xD;
&#xD;
          -  Have received any therapy for smoking cessation during the last month&#xD;
&#xD;
          -  Visceral, systemic or joint inflammatory disease&#xD;
&#xD;
          -  A history of low back surgery&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Prolonged systemic corticosteroid medication&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Recent spinal fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin A Rose, DC, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern California University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Center - Whittier</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>May 18, 2015</last_update_submitted>
  <last_update_submitted_qc>May 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southern California University of Health Sciences</investigator_affiliation>
    <investigator_full_name>KevinRose</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01689168
org study id: ROSE004
nct id: NCT01689168
lead sponsor: 
has dmc: Yes
Tobacco use is the number one killer of Americans today. Most current smokers have tried and
      failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and
      withdrawal from smoking can lead to physical symptoms such as irritability, anxiety,
      nervousness, depression and insomnia.

      This study will examine the effects of tobacco cessation counseling and chiropractic
      treatments on smokers who desire to quit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Tobacco cessation
time frame: Smoking diary will be complete for 3 months
description: Has the subject quit smoking?
measure: Urinary cotinine
time frame: Baseline, 14, 30, 60 and 90 days
description: An urinary test for nicotine metabolites
measure: Blood pressure
time frame: Baseline, 14, 30, 60 days
measure: Weight
time frame: Baseline, 14, 30, 60 days
arm group label: Counseling plus chiropractic adjustments
arm group type: Experimental
arm group label: Counseling alone
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Counseling
description: Tobacco cessation counseling
arm group label: Counseling alone
arm group label: Counseling plus chiropractic adjustments
intervention type: Procedure
intervention name: Chiropractic adjustment
description: Full spine high velocity, low amplitude manipulation of the spine
arm group label: Counseling plus chiropractic adjustments
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin A Rose, DC, MPH
role: Principal Investigator
affiliation: Southern California University of Health Sciences
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Southern California University of Health Sciences
investigator full name: KevinRose
investigator title: Professor