xml: <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/NCT06033365</url>
    </required_header>
    <id_info>
      <org_study_id>22-0968</org_study_id>
      <secondary_id>R01CE003363</secondary_id>
      <nct_id>NCT06033365</nct_id>
    </id_info>
    <brief_title>Beginning Early and Assertive Treatment for Methamphetamine Use Disorder</brief_title>
    <acronym>BEATMeth</acronym>
    <official_title>Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEATMeth): A Comprehensive Systems-level Secondary Prevention Strategy to Prevent Stimulant Related Overdoses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Denver Health and Hospital Authority</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Denver Health and Hospital Authority</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall goal of the study is to evaluate the effectiveness of a secondary prevention&#xD;
        strategy implemented at a systems-level to prevent stimulant related overdoses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To date, a public health systems approach to enhance linkage and engagement in care for&#xD;
        stimulant use disorders is lacking. This shortcoming arises in part from the lack of&#xD;
        effective treatments for stimulant use disorders (StUD), the specific pathology of&#xD;
        methamphetamine use, and gaps in epidemiologic knowledge related to methamphetamine use&#xD;
        disorder. Unlike opioid use disorders, for which medications relieve dysphoric symptoms of&#xD;
        acute withdrawal and prevent relapse, patients with StUD present to care with&#xD;
        methamphetamine-induced psychosis and may be combative, agitated, and poorly insightful to&#xD;
        their need for treatment. In response to community demands, our team at Denver Health&#xD;
        recently established a pilot program, Beginning Early and Assertive Treatment for&#xD;
        Methamphetamine Use Disorder (BEAT Meth), to protocolize the assessment and treatment of&#xD;
        patients with methamphetamine-induced psychosis.The current research project aims to develop&#xD;
        and conduct process and outcomes evaluations of a linkage intervention aimed at increasing&#xD;
        continuation and engagement in treatment for stimulant use disorder.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 11, 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants who entered treatment for methamphetamine use disorder</measure>
      <time_frame>within 30 of study enrollment</time_frame>
      <description>Treatment entry as defined as attendance at an outpatient addiction treatment appointment within 30 days of BEAT Meth discharge</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants retained in treatment at 30 days</measure>
      <time_frame>30 days</time_frame>
      <description>Retention in treatment at 30 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who overdosed</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>non-fatal overdose as self-reported and fatal overdose from medical examiner</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants retained in treatment at 90 days</measure>
      <time_frame>90 days</time_frame>
      <description>Retention in treatment at 90 days</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">182</enrollment>
    <condition>Methamphetamine Use Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dedicated care navigator to address social support needs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard of care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>care navigation</intervention_name>
      <description>Dedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing).</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
            -  identified in the Denver Health healthcare system who have had a&#xD;
               methamphetamine-related encounter at Denver Health&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to complete the interview in English&#xD;
  &#xD;
            -  intoxicated or impaired and unable to consent to participate in the project and/or&#xD;
               respond to the interview&#xD;
  &#xD;
            -  currently under residential involuntary psychiatric or substance treatment order&#xD;
               (i.e., mental health hold, emergency commitment, or short-term certification)&#xD;
  &#xD;
            -  received any type of substance use treatment at DHHA in the last 90 days&#xD;
  &#xD;
            -  planning to enter substance treatment&#xD;
  &#xD;
            -  unable to complete the research visits in the next 90 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alia A Al-Tayyib, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Denver Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alia A Al-Tayyib, PhD</last_name>
      <phone>3036023601</phone>
      <email>alia.al-tayyib@dhha.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Deborah Rinehart, PhD</last_name>
      <phone>3036022743</phone>
      <email>deborah.rinehart@dhha.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Denver Health</name>
        <address>
          <city>Denver</city>
          <state>Colorado</state>
          <zip>80204</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>April 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <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>April 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT06033365/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033365
  org study id: 22-0968
  secondary id: R01CE003363
  nct id: NCT06033365
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The overall goal of the study is to evaluate the effectiveness of a secondary prevention
        strategy implemented at a systems-level to prevent stimulant related overdoses.
  To date, a public health systems approach to enhance linkage and engagement in care for
        stimulant use disorders is lacking. This shortcoming arises in part from the lack of
        effective treatments for stimulant use disorders (StUD), the specific pathology of
        methamphetamine use, and gaps in epidemiologic knowledge related to methamphetamine use
        disorder. Unlike opioid use disorders, for which medications relieve dysphoric symptoms of
        acute withdrawal and prevent relapse, patients with StUD present to care with
        methamphetamine-induced psychosis and may be combative, agitated, and poorly insightful to
        their need for treatment. In response to community demands, our team at Denver Health
        recently established a pilot program, Beginning Early and Assertive Treatment for
        Methamphetamine Use Disorder (BEAT Meth), to protocolize the assessment and treatment of
        patients with methamphetamine-induced psychosis.The current research project aims to develop
        and conduct process and outcomes evaluations of a linkage intervention aimed at increasing
        continuation and engagement in treatment for stimulant use disorder.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Number of participants who entered treatment for methamphetamine use disorder
  time frame: within 30 of study enrollment
  description: Treatment entry as defined as attendance at an outpatient addiction treatment appointment within 30 days of BEAT Meth discharge
  measure: Number of participants retained in treatment at 30 days
  time frame: 30 days
  description: Retention in treatment at 30 days
  measure: Number of participants who overdosed
  time frame: through study completion, an average of 1 year
  description: non-fatal overdose as self-reported and fatal overdose from medical examiner
  measure: Number of participants retained in treatment at 90 days
  time frame: 90 days
  description: Retention in treatment at 90 days
  arm group label: Intervention
  arm group type: Experimental
  description: Dedicated care navigator to address social support needs
  arm group label: Usual care
  arm group type: No Intervention
  description: Standard of care.
  intervention type: Behavioral
  intervention name: care navigation
  description: Dedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing).
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alia A Al-Tayyib, PhD
  role: Principal Investigator
  affiliation: Denver Health
  last name: Alia A Al-Tayyib, PhD
  phone: 3036023601
  email: alia.al-tayyib@dhha.org
  last name: Deborah Rinehart, PhD
  phone: 3036022743
  email: deborah.rinehart@dhha.org
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 