<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/NCT02971137</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-092</org_study_id>
    <nct_id>NCT02971137</nct_id>
  </id_info>
  <brief_title>Pain and Smoking Study</brief_title>
  <acronym>PASS</acronym>
  <official_title>Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this study is to test the telephone delivery of a cognitive behavioral&#xD;
      intervention (CBI), for smoking cessation among Veteran smokers with chronic pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Veterans with chronic pain represent an important population in which to focus smoking&#xD;
      cessation efforts. Smoking cessation among patients with chronic medical illnesses&#xD;
      substantially decreases morbidity and mortality; yet, many patients (&gt;50%) with chronic pain&#xD;
      continue to smoke.&#xD;
&#xD;
      This study aims to test the telephone delivery of a cognitive behavioral intervention (CBI),&#xD;
      for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized&#xD;
      comparative effectiveness trial with a two-group design in which 370 Veteran smokers with&#xD;
      chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an&#xD;
      intervention that includes a proactive tele-health intervention combining evidence-based&#xD;
      smoking cessation counseling augmented with behavioral approaches for coping with pain and a&#xD;
      tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking&#xD;
      cessation telephone counseling control (SMK Control), a contact-equivalent control that&#xD;
      provides standard smoking cessation telephone counseling and a tele-medicine clinic for&#xD;
      accessing NRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2017</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 30, 2021</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>Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)</measure>
    <time_frame>6-month</time_frame>
    <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)</measure>
    <time_frame>12-month post intervention</time_frame>
    <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)</measure>
    <time_frame>6-month post intervention</time_frame>
    <description>30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)</measure>
    <time_frame>12 month post intervention</time_frame>
    <description>30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months</measure>
    <time_frame>Baseline to 6-month post intervention</time_frame>
    <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months</measure>
    <time_frame>Baseline to 6-month post intervention</time_frame>
    <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months</measure>
    <time_frame>Baseline to 12-month post-intervention</time_frame>
    <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Interference, Difference Between Baseline and Interference</measure>
    <time_frame>Baseline to 12-month post intervention</time_frame>
    <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">371</enrollment>
  <condition>Smoking</condition>
  <condition>Pain</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Smoking Cessation plus CBI (SMK-CBI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoking Cessation Standard (SMK-STD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A contact-equivalent control that provides standard smoking cessation telephone counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation plus CBI</intervention_name>
    <description>proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
    <arm_group_label>Smoking Cessation plus CBI (SMK-CBI)</arm_group_label>
    <other_name>SMK-CBI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Standard</intervention_name>
    <description>standard telephone-based smoking cessation intervention</description>
    <arm_group_label>Smoking Cessation Standard (SMK-STD)</arm_group_label>
    <other_name>SMK-STD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans enrolled at VA Connecticut or VA Central Western Massachusetts&#xD;
&#xD;
          -  Current Cigarette Smokers&#xD;
&#xD;
          -  Willing to make quit attempt in next 30 days&#xD;
&#xD;
          -  Pain intensity 4 or greater on scale 0-10, self-reported&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  No access to telephone/Lack of Telephone Access&#xD;
&#xD;
          -  Severely impaired hearing&#xD;
&#xD;
          -  Active diagnosis&#xD;
&#xD;
          -  Terminal Illness&#xD;
&#xD;
          -  Refusal to provide informed consent&#xD;
&#xD;
          -  Enrolled in concurrent smoking cessation programs/research&#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>Lori Anne Bastian, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516-2770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Central Western Massachusetts Healthcare System, Leeds, MA</name>
      <address>
        <city>Leeds</city>
        <state>Massachusetts</state>
        <zip>01053-9764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.</citation>
    <PMID>28340108</PMID>
  </results_reference>
  <results_reference>
    <citation>Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140.</citation>
    <PMID>30203008</PMID>
  </results_reference>
  <results_reference>
    <citation>Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain. Contemp Clin Trials Commun. 2021 Aug 20;23:100839. doi: 10.1016/j.conctc.2021.100839. eCollection 2021 Sep.</citation>
    <PMID>34485755</PMID>
  </results_reference>
  <results_reference>
    <citation>Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for &quot;ineffective&quot; long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2022 Sep 15.</citation>
    <PMID>36448976</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>February 7, 2022</results_first_submitted>
  <results_first_submitted_qc>April 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 4, 2023</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Cigarette Smoking</keyword>
  <keyword>Veterans</keyword>
  <keyword>Tobacco Use</keyword>
  <keyword>Pain</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02971137/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
          <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
        </group>
        <group group_id="P2">
          <title>Smoking Cessation Standard (SMK-STD)</title>
          <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="189"/>
                <participants group_id="P2" count="182"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Veteran population who smoked at least 4 cigarettes a week and pain intesity scores &gt;4 for at least 3 months</population>
      <group_list>
        <group group_id="B1">
          <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
          <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
        </group>
        <group group_id="B2">
          <title>Smoking Cessation Standard (SMK-STD)</title>
          <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="189"/>
            <count group_id="B2" value="182"/>
            <count group_id="B3" value="371"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="46" upper_limit="65"/>
                    <measurement group_id="B2" value="60" lower_limit="53" upper_limit="65"/>
                    <measurement group_id="B3" value="60" lower_limit="52" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="344"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)</title>
        <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
        <time_frame>6-month</time_frame>
        <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 227/371 6m responders, non-responders were assumed to continue smoking</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)</title>
          <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
          <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 227/371 6m responders, non-responders were assumed to continue smoking</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)</title>
        <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
        <time_frame>12-month post intervention</time_frame>
        <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)</title>
          <description>In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?</description>
          <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)</title>
        <description>30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?</description>
        <time_frame>6-month post intervention</time_frame>
        <population>There were 227/371 6m responders, no responders were assumed to continue smoking</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)</title>
          <description>30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?</description>
          <population>There were 227/371 6m responders, no responders were assumed to continue smoking</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)</title>
        <description>30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?</description>
        <time_frame>12 month post intervention</time_frame>
        <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)</title>
          <description>30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?</description>
          <population>Veteran population who smoked at least 4 cigarettes a week and pain intensity scores &gt;4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months</title>
        <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
        <time_frame>Baseline to 6-month post intervention</time_frame>
        <population>14 of the 227 6m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months</title>
          <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
          <population>14 of the 227 6m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.7"/>
                    <measurement group_id="O2" value="-0.5" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months</title>
        <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.</description>
        <time_frame>Baseline to 6-month post intervention</time_frame>
        <population>20 of the 227 6m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months</title>
          <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.</description>
          <population>20 of the 227 6m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.72" spread="2.4"/>
                    <measurement group_id="O2" value="-0.36" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months</title>
        <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
        <time_frame>Baseline to 12-month post-intervention</time_frame>
        <population>24 of the 271 12m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months</title>
          <description>BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.</description>
          <population>24 of the 271 12m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.044" spread="1.6"/>
                    <measurement group_id="O2" value="-0.35" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Interference, Difference Between Baseline and Interference</title>
        <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased</description>
        <time_frame>Baseline to 12-month post intervention</time_frame>
        <population>29 of the 271 12m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
            <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
          </group>
          <group group_id="O2">
            <title>Smoking Cessation Standard (SMK-STD)</title>
            <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Interference, Difference Between Baseline and Interference</title>
          <description>Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased</description>
          <population>29 of the 271 12m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.56" spread="2.3"/>
                    <measurement group_id="O2" value="-.46" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were followed for AE data through duration of their 5 counseling sessions time frame around 3 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Smoking Cessation Plus CBI (SMK-CBI)</title>
          <description>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain&#xD;
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain</description>
        </group>
        <group group_id="E2">
          <title>Smoking Cessation Standard (SMK-STD)</title>
          <description>A contact-equivalent control that provides standard smoking cessation telephone counseling&#xD;
Smoking Cessation Standard: standard telephone-based smoking cessation intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="182"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="182"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="182"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Lori A. Bastian</name_or_title>
      <organization>VA Connecticut Healthcare System</organization>
      <phone>203-932-5711 ext 2655</phone>
      <email>lori.bastian@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02971137
org study id: IIR 15-092
nct id: NCT02971137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This purpose of this study is to test the telephone delivery of a cognitive behavioral
      intervention (CBI), for smoking cessation among Veteran smokers with chronic pain
Veterans with chronic pain represent an important population in which to focus smoking
      cessation efforts. Smoking cessation among patients with chronic medical illnesses
      substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain
      continue to smoke.

      This study aims to test the telephone delivery of a cognitive behavioral intervention (CBI),
      for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized
      comparative effectiveness trial with a two-group design in which 370 Veteran smokers with
      chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an
      intervention that includes a proactive tele-health intervention combining evidence-based
      smoking cessation counseling augmented with behavioral approaches for coping with pain and a
      tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking
      cessation telephone counseling control (SMK Control), a contact-equivalent control that
      provides standard smoking cessation telephone counseling and a tele-medicine clinic for
      accessing NRT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
time frame: 6-month
description: In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
measure: Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
time frame: 12-month post intervention
description: In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
measure: Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
time frame: 6-month post intervention
description: 30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?
measure: Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
time frame: 12 month post intervention
description: 30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?
measure: Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
time frame: Baseline to 6-month post intervention
description: BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
measure: Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
time frame: Baseline to 6-month post intervention
description: Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.
measure: Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
time frame: Baseline to 12-month post-intervention
description: BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
measure: Change in Pain Interference, Difference Between Baseline and Interference
time frame: Baseline to 12-month post intervention
description: Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased
arm group label: Smoking Cessation plus CBI (SMK-CBI)
arm group type: Experimental
description: An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
arm group label: Smoking Cessation Standard (SMK-STD)
arm group type: Active Comparator
description: A contact-equivalent control that provides standard smoking cessation telephone counseling
intervention type: Behavioral
intervention name: Smoking Cessation plus CBI
description: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
arm group label: Smoking Cessation plus CBI (SMK-CBI)
other name: SMK-CBI
intervention type: Behavioral
intervention name: Smoking Cessation Standard
description: standard telephone-based smoking cessation intervention
arm group label: Smoking Cessation Standard (SMK-STD)
other name: SMK-STD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Anne Bastian, MD MPH
role: Principal Investigator
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
facility: 
facility: 
country: United States
citation: Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
PMID: 28340108
citation: Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140.
PMID: 30203008
citation: Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain. Contemp Clin Trials Commun. 2021 Aug 20;23:100839. doi: 10.1016/j.conctc.2021.100839. eCollection 2021 Sep.
PMID: 34485755
citation: Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2022 Sep 15.
PMID: 36448976
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.
point of contact: 