<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/NCT01723163</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 12-365</org_study_id>
    <nct_id>NCT01723163</nct_id>
  </id_info>
  <brief_title>Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers</brief_title>
  <official_title>Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of the current study is to evaluate the effectiveness of a combined&#xD;
      tele-health and contingency management (CM) intervention that investigators are calling&#xD;
      Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a&#xD;
      two-group design in which 310 Veteran smokers will be randomized to either:&#xD;
&#xD;
      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines&#xD;
      guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for&#xD;
      access to nicotine replacement (NRT), and intensive behavioral therapy through mobile&#xD;
      contingency management.&#xD;
&#xD;
      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide&#xD;
      controls for therapist, medication, time and attention effects. The tele-health intervention&#xD;
      provides the same guideline based cognitive-behavioral smoking cessation telephone counseling&#xD;
      (TC), and tele-medicine clinic for access to NRT as in the ART intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The addition of contingency management (CM) to existing evidenced-based tele-health smoking&#xD;
      cessation interventions is expected to be a cost-effective way to increase the reach of&#xD;
      intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides&#xD;
      positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent&#xD;
      upon objective evidence of abstinence from drug use. Implementation of CM has been limited&#xD;
      because of the need to verify abstinence multiple times daily with a clinic based carbon&#xD;
      monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient&#xD;
      and day treatment programs. The application of emerging smart-phone technology, however, can&#xD;
      overcome this barrier. Investigators have developed a smart-phone application which allows a&#xD;
      participant to video themselves several times daily while using a small CO monitor and to&#xD;
      transmit the data to a secure server. This innovation has made the use of CM for outpatient&#xD;
      smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the&#xD;
      current study is to evaluate the effectiveness of a combined tele-health and CM intervention&#xD;
      that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a&#xD;
      comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be&#xD;
      randomized to either:&#xD;
&#xD;
      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines&#xD;
      guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for&#xD;
      access to nicotine replacement (NRT), and intensive behavioral therapy through mobile&#xD;
      contingency management.&#xD;
&#xD;
      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide&#xD;
      controls for therapist, medication, time and attention effects. The tele-health intervention&#xD;
      provides the same guideline based cognitive-behavioral smoking cessation telephone counseling&#xD;
      (TC), and tele-medicine clinic for access to NRT as in the ART intervention.&#xD;
&#xD;
      Both of the proposed interventions are designed in accordance with national smoking cessation&#xD;
      guidelines. Tele-health smoking cessation interventions are typically less intensive than&#xD;
      clinic based specialty care, but increase reach of services through bypassing barriers to&#xD;
      participation such as geographical distance from VA care. The addition of mCM to an&#xD;
      evidence-based tele-health smoking intervention will significantly increase the intensity of&#xD;
      the intervention and is predicted to increase efficacy. If cessation programs are to have&#xD;
      significant impact (Impact = Reach X Efficacy) on changing health behavior at the population&#xD;
      level, investigators must identify new and innovative strategies to increase treatment&#xD;
      intensity, access, and participation.&#xD;
&#xD;
      The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at&#xD;
      3-month, 6-month, and 12-month post-randomization follow-ups.&#xD;
&#xD;
      Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the&#xD;
      ART-based intervention than those randomized to the Tele-health alone intervention (primary&#xD;
      end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2013</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2016</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 With Abstinence or Non-Abstinence at 6-month Follow-up</measure>
    <time_frame>6-month post-treatment</time_frame>
    <description>Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Veteran</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abstinence Reinforcement Therapy (ART)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Telephone Counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Abstinence Reinforcement Therapy (ART)</intervention_name>
    <description>Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone Counseling and NRT</intervention_name>
    <description>Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the Durham VA for ongoing care.&#xD;
&#xD;
          -  Current smokers planning to quit smoking in the next 30 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active diagnosis of psychosis documented in the medical record.&#xD;
&#xD;
          -  Does not have access to a telephone.&#xD;
&#xD;
          -  Severely impaired hearing or speech (Veterans must be able to respond to phone calls).&#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>Patrick S Calhoun, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10.</citation>
    <PMID>27521811</PMID>
  </results_reference>
  <results_reference>
    <citation>Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh.2016.03.004. Epub 2016 Mar 11.</citation>
    <PMID>27046670</PMID>
  </results_reference>
  <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>Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup; Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14.</citation>
    <PMID>28808856</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>December 14, 2017</results_first_submitted>
  <results_first_submitted_qc>October 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2019</results_first_posted>
  <last_update_submitted>October 24, 2018</last_update_submitted>
  <last_update_submitted_qc>October 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>veteran</keyword>
  <keyword>smoking cessation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Abstinence Reinforcement Therapy (ART)&#xD;
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Telephone Counseling&#xD;
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by PI</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3-Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to Contact</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to Contact</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to Contact</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Abstinence Reinforcement Therapy (ART)&#xD;
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Telephone Counseling&#xD;
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)</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="156"/>
            <count group_id="B2" value="154"/>
            <count group_id="B3" value="310"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="11"/>
                    <measurement group_id="B2" value="56" spread="11"/>
                    <measurement group_id="B3" value="57" spread="11"/>
                  </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="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="276"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="305"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>More than High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School or less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance to nearest VA hospital or clinic (miles)</title>
          <description>Distance from the participant's home to the nearest VA hospital or VA clinic (in miles).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0-20 Miles</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>21-40 Miles</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>41-60 Miles</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>61-80 Miles</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>81-100 Miles</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>101 Miles or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom Test for Nicotine Dependence</title>
          <description>Scores can range from 0-10; higher scores reflect a higher level of nicotine dependence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" spread="2"/>
                    <measurement group_id="B2" value="4" spread="2"/>
                    <measurement group_id="B3" value="4" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self efficacy scale for quitting smoking in next 6 months</title>
          <description>1=not at all to 7=very confident</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" spread="1"/>
                    <measurement group_id="B2" value="6" spread="1"/>
                    <measurement group_id="B3" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up</title>
        <description>Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.</description>
        <time_frame>6-month post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Abstinence Reinforcement Therapy (ART)&#xD;
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Telephone Counseling&#xD;
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up</title>
          <description>Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abstinent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Abstinent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Abstinence Reinforcement Therapy (ART)&#xD;
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Telephone Counseling&#xD;
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)</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="2" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="154"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Patrick Calhoun</name_or_title>
      <organization>Durham Veterans Affairs Medical Center</organization>
      <phone>919-286-0411 ext 7970</phone>
      <email>patrick.calhoun2@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/NCT01723163
org study id: IIR 12-365
nct id: NCT01723163
lead sponsor: 
has dmc: No
The primary goal of the current study is to evaluate the effectiveness of a combined
      tele-health and contingency management (CM) intervention that investigators are calling
      Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a
      two-group design in which 310 Veteran smokers will be randomized to either:

      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines
      guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for
      access to nicotine replacement (NRT), and intensive behavioral therapy through mobile
      contingency management.

      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide
      controls for therapist, medication, time and attention effects. The tele-health intervention
      provides the same guideline based cognitive-behavioral smoking cessation telephone counseling
      (TC), and tele-medicine clinic for access to NRT as in the ART intervention.
The addition of contingency management (CM) to existing evidenced-based tele-health smoking
      cessation interventions is expected to be a cost-effective way to increase the reach of
      intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides
      positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent
      upon objective evidence of abstinence from drug use. Implementation of CM has been limited
      because of the need to verify abstinence multiple times daily with a clinic based carbon
      monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient
      and day treatment programs. The application of emerging smart-phone technology, however, can
      overcome this barrier. Investigators have developed a smart-phone application which allows a
      participant to video themselves several times daily while using a small CO monitor and to
      transmit the data to a secure server. This innovation has made the use of CM for outpatient
      smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the
      current study is to evaluate the effectiveness of a combined tele-health and CM intervention
      that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a
      comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be
      randomized to either:

      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines
      guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for
      access to nicotine replacement (NRT), and intensive behavioral therapy through mobile
      contingency management.

      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide
      controls for therapist, medication, time and attention effects. The tele-health intervention
      provides the same guideline based cognitive-behavioral smoking cessation telephone counseling
      (TC), and tele-medicine clinic for access to NRT as in the ART intervention.

      Both of the proposed interventions are designed in accordance with national smoking cessation
      guidelines. Tele-health smoking cessation interventions are typically less intensive than
      clinic based specialty care, but increase reach of services through bypassing barriers to
      participation such as geographical distance from VA care. The addition of mCM to an
      evidence-based tele-health smoking intervention will significantly increase the intensity of
      the intervention and is predicted to increase efficacy. If cessation programs are to have
      significant impact (Impact = Reach X Efficacy) on changing health behavior at the population
      level, investigators must identify new and innovative strategies to increase treatment
      intensity, access, and participation.

      The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at
      3-month, 6-month, and 12-month post-randomization follow-ups.

      Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the
      ART-based intervention than those randomized to the Tele-health alone intervention (primary
      end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
time frame: 6-month post-treatment
description: Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.
arm group label: Intervention
arm group type: Experimental
description: Abstinence Reinforcement Therapy (ART)
arm group label: Control
arm group type: Other
description: Telephone Counseling
intervention type: Behavioral
intervention name: Abstinence Reinforcement Therapy (ART)
description: Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
arm group label: Intervention
other name: Intervention
intervention type: Behavioral
intervention name: Telephone Counseling and NRT
description: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
arm group label: Control
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick S Calhoun, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
citation: Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10.
PMID: 27521811
citation: Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh.2016.03.004. Epub 2016 Mar 11.
PMID: 27046670
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: Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup; Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14.
PMID: 28808856
responsible party type: Sponsor
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 