<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/NCT04464421</url>
  </required_header>
  <id_info>
    <org_study_id>20-07418-XP UM</org_study_id>
    <nct_id>NCT04464421</nct_id>
  </id_info>
  <brief_title>SMART Trial Efficacy Study</brief_title>
  <official_title>Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karen Derefinko, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Memphis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of two different interventions for&#xD;
      medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief&#xD;
      Motivational Intervention plus Substance Free Activities Session plus Mindfulness-Based&#xD;
      Adherence Promotion (BMI+SFAS+MBAP). If the interventions are efficacious, they will be used&#xD;
      in a larger trial with a SMART (Sequential Multiple Assignment Randomized Trial) design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will engage with referred OUD patients at the time of their initial visit to the CAS.&#xD;
      Interested patients will be informed about the study in a private room, and if eligible, will&#xD;
      be consented and randomized to condition. Randomization will occur in blocks of 4. At the&#xD;
      next physician visit, participants will engage in their first treatment activities (either&#xD;
      payment of $25 for buprenorphine positive/illicit opioid negative saliva screen for those in&#xD;
      CM, or their first BMI+SFAS with an Interventionist). This will be repeated for the following&#xD;
      3 weeks.&#xD;
&#xD;
      CM. Those randomized to the CM intervention will receive $25 gift certificates to Amazon for&#xD;
      each of the illicit opioid-negative, buprenorphine-positive saliva screens obtained at&#xD;
      physician visits. During the pilot trial, 4 clean saliva screens (one each week) will result&#xD;
      in a $100 bonus.&#xD;
&#xD;
      BMI+SFAS. Those randomized to the BMI+SFAS will engage in a weekly discussion of several&#xD;
      areas known to reduce delay discounting and improve decision-making. Topic areas include:&#xD;
      Short and Long-Term Goals: identifying goals (e.g., What are your goals for this month…for&#xD;
      the next 5 years? What would you like to have accomplished?), requirements needed to achieve&#xD;
      these goals (e.g., What would you need to do to achieve those goals?) and the potential role&#xD;
      of illicit opioid use in jeopardizing these goals; Reward Bundling: aggregate global&#xD;
      day-to-day choices and activities into cumulative, cohesive patterns that relate to&#xD;
      personally relevant long-term health or social outcomes.86,87 A behavior with immediate but&#xD;
      low reward value (i.e., taking a daily dose of buprenorphine-naloxone) in the short-term may&#xD;
      have higher reward value when it is framed as part of a pattern of achieving a valued&#xD;
      long-term outcome (i.e., steady employment at a desired job); Episodic Future Thinking88,89:&#xD;
      An experiential intervention that prompts individuals to describe personal, emotional, and&#xD;
      situational details of a valued future outcome in great detail (e.g., what it would be like&#xD;
      to regain family trust or get a career-job); Substance Free Activities: Participants will be&#xD;
      offered a menu of substance free activities that has been developed in pilot work. Activities&#xD;
      will be discussed, and participants will be asked to engage in selected activities as&#xD;
      homework. Engagement in substance free activities will be assessed at each subsequent visit.&#xD;
      This weekly intervention will take 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Who Were Adherent to Treatment</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>Defined as no negative buprenorphine urine tests and attendance of at least two visits.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Opioid Dependence</condition>
  <condition>Treatment Adherence</condition>
  <arm_group>
    <arm_group_label>Contingency management (CM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BSM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contingency Management (CM)</intervention_name>
    <description>Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.</description>
    <arm_group_label>Contingency management (CM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)</intervention_name>
    <description>Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.</description>
    <arm_group_label>BSM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Present for an intake appointment at study site for treatment of opioid use disorder.&#xD;
&#xD;
          -  Eligible for receipt of buprenorphine-naloxone treatment (e.g. Suboxone, Bunavil,&#xD;
             Zubsolv) as determined by clinic physicians&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Access to a telephone&#xD;
&#xD;
          -  Ability to comprehend consent and intervention materials (approximately 8th-grade&#xD;
             level).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physician expects that patient will not follow standard treatment visit schedule&#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>Karen J Derefinko, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <results_first_submitted>March 28, 2022</results_first_submitted>
  <results_first_submitted_qc>March 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2022</results_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Tennessee</investigator_affiliation>
    <investigator_full_name>Karen Derefinko, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>opioid use disorder</keyword>
  <keyword>OUD</keyword>
  <keyword>buprenorphine</keyword>
  <keyword>treatment adherence</keyword>
  <keyword>substance-free activities</keyword>
  <keyword>brief motivational interviewing</keyword>
  <keyword>contingency management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04464421/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04464421/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04464421/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Contingency Management (CM)</title>
          <description>Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.&#xD;
Contingency Management (CM): Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.</description>
        </group>
        <group group_id="P2">
          <title>Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion</title>
          <description>BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.&#xD;
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM): Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>48 participants were randomized, but 4 never completed baseline/demographics assessments leaving N=44 with 22 in each arm.</population>
      <group_list>
        <group group_id="B1">
          <title>Contingency Management (CM)</title>
          <description>Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.&#xD;
Contingency Management (CM): Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.</description>
        </group>
        <group group_id="B2">
          <title>Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion</title>
          <description>BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.&#xD;
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM): Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.</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="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="44"/>
          </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="39.45" spread="10.75"/>
                    <measurement group_id="B2" value="35.41" spread="9.88"/>
                    <measurement group_id="B3" value="37.43" spread="10.41"/>
                  </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </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="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Who Were Adherent to Treatment</title>
        <description>Defined as no negative buprenorphine urine tests and attendance of at least two visits.</description>
        <time_frame>through study completion, an average of 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Contingency Management (CM)</title>
            <description>Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.&#xD;
Contingency Management (CM): Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.</description>
          </group>
          <group group_id="O2">
            <title>Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion</title>
            <description>BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.&#xD;
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM): Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Were Adherent to Treatment</title>
          <description>Defined as no negative buprenorphine urine tests and attendance of at least two visits.</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="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were systematically assessed for adverse events throughout their participation in the study which lasted for 6 months from baseline.</time_frame>
      <desc>Clinicaltrials.gov definitions were used.</desc>
      <group_list>
        <group group_id="E1">
          <title>Contingency Management (CM)</title>
          <description>Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.&#xD;
Contingency Management (CM): Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.</description>
        </group>
        <group group_id="E2">
          <title>Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion</title>
          <description>BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.&#xD;
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM): Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Incomplete spinal fusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Karen Derefinko, PhD</name_or_title>
      <organization>University of Tennessee Health Science Center</organization>
      <phone>9014482526</phone>
      <email>kderefin@uthsc.edu</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/NCT04464421
org study id: 20-07418-XP UM
nct id: NCT04464421
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of two different interventions for
      medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief
      Motivational Intervention plus Substance Free Activities Session plus Mindfulness-Based
      Adherence Promotion (BMI+SFAS+MBAP). If the interventions are efficacious, they will be used
      in a larger trial with a SMART (Sequential Multiple Assignment Randomized Trial) design.
We will engage with referred OUD patients at the time of their initial visit to the CAS.
      Interested patients will be informed about the study in a private room, and if eligible, will
      be consented and randomized to condition. Randomization will occur in blocks of 4. At the
      next physician visit, participants will engage in their first treatment activities (either
      payment of $25 for buprenorphine positive/illicit opioid negative saliva screen for those in
      CM, or their first BMI+SFAS with an Interventionist). This will be repeated for the following
      3 weeks.

      CM. Those randomized to the CM intervention will receive $25 gift certificates to Amazon for
      each of the illicit opioid-negative, buprenorphine-positive saliva screens obtained at
      physician visits. During the pilot trial, 4 clean saliva screens (one each week) will result
      in a $100 bonus.

      BMI+SFAS. Those randomized to the BMI+SFAS will engage in a weekly discussion of several
      areas known to reduce delay discounting and improve decision-making. Topic areas include:
      Short and Long-Term Goals: identifying goals (e.g., What are your goals for this month…for
      the next 5 years? What would you like to have accomplished?), requirements needed to achieve
      these goals (e.g., What would you need to do to achieve those goals?) and the potential role
      of illicit opioid use in jeopardizing these goals; Reward Bundling: aggregate global
      day-to-day choices and activities into cumulative, cohesive patterns that relate to
      personally relevant long-term health or social outcomes.86,87 A behavior with immediate but
      low reward value (i.e., taking a daily dose of buprenorphine-naloxone) in the short-term may
      have higher reward value when it is framed as part of a pattern of achieving a valued
      long-term outcome (i.e., steady employment at a desired job); Episodic Future Thinking88,89:
      An experiential intervention that prompts individuals to describe personal, emotional, and
      situational details of a valued future outcome in great detail (e.g., what it would be like
      to regain family trust or get a career-job); Substance Free Activities: Participants will be
      offered a menu of substance free activities that has been developed in pilot work. Activities
      will be discussed, and participants will be asked to engage in selected activities as
      homework. Engagement in substance free activities will be assessed at each subsequent visit.
      This weekly intervention will take 30 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Proportion of Participants Who Were Adherent to Treatment
time frame: through study completion, an average of 4 months
description: Defined as no negative buprenorphine urine tests and attendance of at least two visits.
arm group label: Contingency management (CM)
arm group type: Experimental
description: Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.
arm group label: BSM
arm group type: Experimental
description: BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.
intervention type: Behavioral
intervention name: Contingency Management (CM)
description: Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.
arm group label: Contingency management (CM)
intervention type: Behavioral
intervention name: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)
description: Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.
arm group label: BSM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen J Derefinko, PhD
role: Principal Investigator
affiliation: University of Tennessee
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Tennessee
investigator full name: Karen Derefinko, PhD
investigator title: Assistant Professor
mesh term: Opioid-Related Disorders
sharing ipd: Undecided
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 