<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/NCT02994043</url>
  </required_header>
  <id_info>
    <org_study_id>20-2550</org_study_id>
    <secondary_id>R01AA024632</secondary_id>
    <nct_id>NCT02994043</nct_id>
  </id_info>
  <brief_title>Alcohol, Inflammation, and Mindfulness Study (AIM)</brief_title>
  <official_title>Dismantling MBRP: Identifying Critical Neuroimmune Mechanisms of Action.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse&#xD;
      Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders&#xD;
      (AUD) by implementing an 8-week long intervention and examining neurobiological,&#xD;
      immunological, and epigenetic characteristics of AUD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was designed to evaluate the effect of two outpatient, individually-administered,&#xD;
      psychosocial interventions (Relapse Prevention vs. Mindfulness-Based Relapse Prevention).&#xD;
      Participants are recruited via mass media advertisements, flyers, and local outreach to&#xD;
      clinical providers that do not address substance use. We will recruit 226 individuals. Our&#xD;
      previous experience with clinical trials, as well as the experience of our research team&#xD;
      members with these interventions support the feasibility of recruiting approximately 50&#xD;
      patients per year. This sample size provides adequate statistical power for the research&#xD;
      questions undertaken.&#xD;
&#xD;
      Participants are screened over the telephone and invited into the laboratory for a baseline&#xD;
      assessment. Immediately after the baseline assessment, they are randomized to a therapist and&#xD;
      then to a treatment condition. At the end of each year, the distribution of participants&#xD;
      across conditions and therapists are evaluated for imbalances. If attrition has resulted in&#xD;
      an imbalance across conditions, the randomization procedure will be adjusted to ensure equal&#xD;
      numbers of participants in RP and MBRP.&#xD;
&#xD;
      Within a week of completing the baseline assessments, participants are seen by their&#xD;
      individual therapist for a motivational interviewing, goal-setting session. After the&#xD;
      goal-setting session, the eight-session MBRP or RP treatments are administered. To ensure&#xD;
      that therapists adhere to treatment manuals, a checklist is provided consisting of the&#xD;
      primary content addressed each session (four to seven primary content pieces each session).&#xD;
      Further, questionnaires assessing mindfulness practice and facets of mindfulness (e.g., being&#xD;
      nonjudgmental, nonreactive) are administered at each assessment. At the most recent RPPR,&#xD;
      these questionnaires validated that participants in the MBRP condition were increasing in&#xD;
      some facets of mindfulness during treatment (and up to three months after treatment).&#xD;
&#xD;
      We estimate that the completion of assessments and procedures across the duration of the&#xD;
      trial, excluding therapy sessions, will total about 15 hours of time. To compensate subjects&#xD;
      for their time and travel costs, each subject will be paid $300 if they complete all&#xD;
      sessions.&#xD;
&#xD;
      We will conduct extensive analyses of any attrition encountered in the project to determine&#xD;
      bias. However, note that in each of the analyses described herein, we will have the&#xD;
      capability of using modern approaches to the handling of missing data including full&#xD;
      information maximum likelihood estimation of missing data within Proc Mixed in SAS and within&#xD;
      EQS.&#xD;
&#xD;
      The distributional properties of all continuously scaled variables will be examined for&#xD;
      skewness and kurtosis to determine the need for normalizing transformations or for&#xD;
      alternations to our analysis plan (i.e., generalized estimating equations or robust&#xD;
      estimation) prior to the primary analyses.&#xD;
&#xD;
      To confirm the validity of random assignment, pretest equivalence of the two treatment&#xD;
      conditions across demographics, drinking history, smoking, and all other baseline measures&#xD;
      will be assessed via t-tests on continuous items and c2 tests of categorical items. We will&#xD;
      use the Bonferroni approach to correct for alpha inflation with a familywise alpha of .05.&#xD;
      Any variables on which the two groups are unequal at pretest will be covariates in all&#xD;
      further analyses.&#xD;
&#xD;
      Attrition analyses will be conducted after each follow-up data collection effort to provide&#xD;
      assurance that differential attrition by treatment condition has not occurred. Following&#xD;
      previously published procedures, a series of ANOVAs of treatment (MBRP versus RP) X retention&#xD;
      (retained, not retained) will be conducted on continuous baseline measures. Significant&#xD;
      treatment X retention interactions identify measured variables on which differential&#xD;
      attrition may have occurred. The logit model analog procedure will be applied to categorical&#xD;
      baseline measures to test for differential attrition on categorical variables such as gender&#xD;
      and ethnicity. We will conduct these analyses to assure that differential attrition by&#xD;
      treatment condition does not account for any of the effects of the treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2016</start_date>
  <completion_date type="Actual">February 17, 2021</completion_date>
  <primary_completion_date type="Actual">February 17, 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>Heavy Drinking Days at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heavy Drinking Days at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heavy Drinking Days at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heavy Drinking Days at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heavy Drinking Days at Week 32</measure>
    <time_frame>Week 32</time_frame>
    <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>MBRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-Based Relapse Prevention Therapy</intervention_name>
    <description>An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
    <arm_group_label>MBRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relapse Prevention Therapy</intervention_name>
    <description>An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
    <arm_group_label>RP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a primary Diagnostic Statistical Manual-V (DSM-V) diagnosis of alcohol use&#xD;
             disorder;&#xD;
&#xD;
          2. Must be within 10 days of last drink;&#xD;
&#xD;
          3. Must have been drinking heavily (criteria dependent upon individual?s age, gender, and&#xD;
             BMI) for a consistent period of time;&#xD;
&#xD;
          4. Must have a breath alcohol level of 0 at screening;&#xD;
&#xD;
          5. Must have a Clinical Institute Withdrawal Assessment (CIWA) score less than 8&#xD;
             (indicating no need for medical detox);&#xD;
&#xD;
          6. Must have expressed a desire during their initial screen to reduce the number of&#xD;
             drinks they regularly consume&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently taking any medications for the treatment of psychiatric disorders, including&#xD;
             substance use disorders, mood disorders, and psychosis;&#xD;
&#xD;
          2. Pregnant, as indicated by a pregnancy test which will be administered at baseline;&#xD;
&#xD;
          3. Positive for, sedatives, opiates, cocaine, or amphetamine on drug screen at baseline;&#xD;
&#xD;
          4. Meets criteria for psychotic disorder, bipolar disorder, or a major depressive episode&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ken Hutchison</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado Denver | Anschutz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>December 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2023</results_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <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>July 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02994043/Prot_SAP_000.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>July 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02994043/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness-Based Relapse Prevention</title>
          <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
        </group>
        <group group_id="P2">
          <title>Relapse Prevention</title>
          <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MBRP</title>
          <description>Mindfulness Plus Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
        </group>
        <group group_id="B2">
          <title>Relapse Prevention</title>
          <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</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="90"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="182"/>
          </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="44.1" spread="10.0"/>
                    <measurement group_id="B2" value="44.2" spread="10.3"/>
                    <measurement group_id="B3" value="44.2" spread="10.1"/>
                  </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="40"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="94"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heavy Drinking Days at Baseline</title>
        <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-Based Relapse Prevention</title>
            <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
          </group>
          <group group_id="O2">
            <title>Relapse Prevention</title>
            <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
          </group>
        </group_list>
        <measure>
          <title>Heavy Drinking Days at Baseline</title>
          <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
          <units>Heavy Drinking Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="10.3"/>
                    <measurement group_id="O2" value="11.7" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heavy Drinking Days at Week 4</title>
        <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-Based Relapse Prevention</title>
            <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
          </group>
          <group group_id="O2">
            <title>Relapse Prevention</title>
            <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
          </group>
        </group_list>
        <measure>
          <title>Heavy Drinking Days at Week 4</title>
          <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
          <units>Heavy Drinking Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="8.2"/>
                    <measurement group_id="O2" value="7.6" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heavy Drinking Days at Week 8</title>
        <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-Based Relapse Prevention</title>
            <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
          </group>
          <group group_id="O2">
            <title>Relapse Prevention</title>
            <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
          </group>
        </group_list>
        <measure>
          <title>Heavy Drinking Days at Week 8</title>
          <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
          <units>Heavy Drinking Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="7.9"/>
                    <measurement group_id="O2" value="5.3" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heavy Drinking Days at Week 20</title>
        <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
        <time_frame>Week 20</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-Based Relapse Prevention</title>
            <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
          </group>
          <group group_id="O2">
            <title>Relapse Prevention</title>
            <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
          </group>
        </group_list>
        <measure>
          <title>Heavy Drinking Days at Week 20</title>
          <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
          <units>Heavy Drinking Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="8.0"/>
                    <measurement group_id="O2" value="7.3" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heavy Drinking Days at Week 32</title>
        <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
        <time_frame>Week 32</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-Based Relapse Prevention</title>
            <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
          </group>
          <group group_id="O2">
            <title>Relapse Prevention</title>
            <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</description>
          </group>
        </group_list>
        <measure>
          <title>Heavy Drinking Days at Week 32</title>
          <description>Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)</description>
          <units>Heavy Drinking Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="6.5"/>
                    <measurement group_id="O2" value="7.7" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>32 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness-Based Relapse Prevention</title>
          <description>Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.</description>
        </group>
        <group group_id="E2">
          <title>Relapse Prevention</title>
          <description>Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.</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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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>Jamie Laurin</name_or_title>
      <organization>University of Colorado Denver</organization>
      <phone>303-724-3183</phone>
      <email>JAIME.LAURIN@CUANSCHUTZ.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/NCT02994043
org study id: 20-2550
secondary id: R01AA024632
nct id: NCT02994043
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse
      Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders
      (AUD) by implementing an 8-week long intervention and examining neurobiological,
      immunological, and epigenetic characteristics of AUD.
This study was designed to evaluate the effect of two outpatient, individually-administered,
      psychosocial interventions (Relapse Prevention vs. Mindfulness-Based Relapse Prevention).
      Participants are recruited via mass media advertisements, flyers, and local outreach to
      clinical providers that do not address substance use. We will recruit 226 individuals. Our
      previous experience with clinical trials, as well as the experience of our research team
      members with these interventions support the feasibility of recruiting approximately 50
      patients per year. This sample size provides adequate statistical power for the research
      questions undertaken.

      Participants are screened over the telephone and invited into the laboratory for a baseline
      assessment. Immediately after the baseline assessment, they are randomized to a therapist and
      then to a treatment condition. At the end of each year, the distribution of participants
      across conditions and therapists are evaluated for imbalances. If attrition has resulted in
      an imbalance across conditions, the randomization procedure will be adjusted to ensure equal
      numbers of participants in RP and MBRP.

      Within a week of completing the baseline assessments, participants are seen by their
      individual therapist for a motivational interviewing, goal-setting session. After the
      goal-setting session, the eight-session MBRP or RP treatments are administered. To ensure
      that therapists adhere to treatment manuals, a checklist is provided consisting of the
      primary content addressed each session (four to seven primary content pieces each session).
      Further, questionnaires assessing mindfulness practice and facets of mindfulness (e.g., being
      nonjudgmental, nonreactive) are administered at each assessment. At the most recent RPPR,
      these questionnaires validated that participants in the MBRP condition were increasing in
      some facets of mindfulness during treatment (and up to three months after treatment).

      We estimate that the completion of assessments and procedures across the duration of the
      trial, excluding therapy sessions, will total about 15 hours of time. To compensate subjects
      for their time and travel costs, each subject will be paid $300 if they complete all
      sessions.

      We will conduct extensive analyses of any attrition encountered in the project to determine
      bias. However, note that in each of the analyses described herein, we will have the
      capability of using modern approaches to the handling of missing data including full
      information maximum likelihood estimation of missing data within Proc Mixed in SAS and within
      EQS.

      The distributional properties of all continuously scaled variables will be examined for
      skewness and kurtosis to determine the need for normalizing transformations or for
      alternations to our analysis plan (i.e., generalized estimating equations or robust
      estimation) prior to the primary analyses.

      To confirm the validity of random assignment, pretest equivalence of the two treatment
      conditions across demographics, drinking history, smoking, and all other baseline measures
      will be assessed via t-tests on continuous items and c2 tests of categorical items. We will
      use the Bonferroni approach to correct for alpha inflation with a familywise alpha of .05.
      Any variables on which the two groups are unequal at pretest will be covariates in all
      further analyses.

      Attrition analyses will be conducted after each follow-up data collection effort to provide
      assurance that differential attrition by treatment condition has not occurred. Following
      previously published procedures, a series of ANOVAs of treatment (MBRP versus RP) X retention
      (retained, not retained) will be conducted on continuous baseline measures. Significant
      treatment X retention interactions identify measured variables on which differential
      attrition may have occurred. The logit model analog procedure will be applied to categorical
      baseline measures to test for differential attrition on categorical variables such as gender
      and ethnicity. We will conduct these analyses to assure that differential attrition by
      treatment condition does not account for any of the effects of the treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Heavy Drinking Days at Baseline
time frame: Baseline
description: Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
measure: Heavy Drinking Days at Week 4
time frame: Week 4
description: Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
measure: Heavy Drinking Days at Week 8
time frame: Week 8
description: Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
measure: Heavy Drinking Days at Week 20
time frame: Week 20
description: Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
measure: Heavy Drinking Days at Week 32
time frame: Week 32
description: Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
arm group label: MBRP
arm group type: Active Comparator
arm group label: RP
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Mindfulness-Based Relapse Prevention Therapy
description: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
arm group label: MBRP
intervention type: Behavioral
intervention name: Relapse Prevention Therapy
description: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.
arm group label: RP
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ken Hutchison
role: Principal Investigator
affiliation: University of Colorado Denver | Anschutz
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 