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/NCT06001437</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000766</org_study_id>
      <secondary_id>3UG1DA015831-21S4</secondary_id>
      <nct_id>NCT06001437</nct_id>
    </id_info>
    <brief_title>Following Outcomes Remotely Within Addiction Recovery Domains</brief_title>
    <acronym>FORWARD</acronym>
    <official_title>CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mclean Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Mclean Hospital</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 aim of this study is to describe outcome of people with opioid use disorder over the&#xD;
        long-term by collecting monthly and yearly data on their recovery. Adults with opioid use&#xD;
        disorder who participate will complete surveys monthly online and once per year by phone&#xD;
        about their substance use, mental health, treatment involvement and functioning. The goal of&#xD;
        this study is to better understand how people with opioid use disorder recover over time to&#xD;
        improve intervention for this group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a longitudinal follow-up study that will collect yearly outcomes data on adults with&#xD;
        opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA&#xD;
        Clinical Trials Network. This longitudinal, observational study will entail annual phone and&#xD;
        online assessments of domains of interest (e.g., substance use, treatment engagement) as well&#xD;
        as monthly assessments that are distributed via text messaging and email to be completed&#xD;
        electronically by the participant. No participant randomization will occur for this study,&#xD;
        and study data will be considered observational in nature. We aim to characterize the&#xD;
        long-term course of OUD and to evaluate the long-term course and recovery of OUD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Opioid Use</measure>
      <time_frame>12 months</time_frame>
      <description>Count of months of opioid use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Engagement in Treatment</measure>
      <time_frame>12 months</time_frame>
      <description>Count of months engaged in treatment for opioid use disorder</description>
    </primary_outcome>
    <enrollment type="Anticipated">1600</enrollment>
    <condition>Opioid Use Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with opioid use disorder who have previously participated in one of two applicable&#xD;
          opioid use disorder clinical trials in the NIDA Clinical Trials Network.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be an enrolled participant in one of two applicable clinical trials and be no longer&#xD;
               than 24 months after the final expected assessment for that trial.&#xD;
  &#xD;
            2. Be willing and able to provide locator information for survey distribution (mobile&#xD;
               number and/or email address).&#xD;
  &#xD;
            3. Be willing to allow the linkage of prior clinical trial study data to the current&#xD;
               study record.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable to understand or communicate to complete consent or study assessments.&#xD;
  &#xD;
            2. Are currently in jail, prison or other overnight facility as required by court of law&#xD;
               or have pending legal action that could prevent participation in study activities.&#xD;
  &#xD;
            3. Other factors that would cause harm or increased risk to the participant or close&#xD;
               contacts or preclude the participant's full adherence with or completion of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mclean Hospital</investigator_affiliation>
      <investigator_full_name>McHugh, R. Kathryn</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06001437
  org study id: 2023P000766
  secondary id: 3UG1DA015831-21S4
  nct id: NCT06001437
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to describe outcome of people with opioid use disorder over the
        long-term by collecting monthly and yearly data on their recovery. Adults with opioid use
        disorder who participate will complete surveys monthly online and once per year by phone
        about their substance use, mental health, treatment involvement and functioning. The goal of
        this study is to better understand how people with opioid use disorder recover over time to
        improve intervention for this group.
  This is a longitudinal follow-up study that will collect yearly outcomes data on adults with
        opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA
        Clinical Trials Network. This longitudinal, observational study will entail annual phone and
        online assessments of domains of interest (e.g., substance use, treatment engagement) as well
        as monthly assessments that are distributed via text messaging and email to be completed
        electronically by the participant. No participant randomization will occur for this study,
        and study data will be considered observational in nature. We aim to characterize the
        long-term course of OUD and to evaluate the long-term course and recovery of OUD.
  observational model: Cohort
  time perspective: Prospective
  measure: Opioid Use
  time frame: 12 months
  description: Count of months of opioid use.
  measure: Engagement in Treatment
  time frame: 12 months
  description: Count of months engaged in treatment for opioid use disorder
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  responsible party type: Principal Investigator
  investigator affiliation: Mclean Hospital
  investigator full name: McHugh, R. Kathryn
  investigator title: Associate Professor
  mesh term: Opioid-Related Disorders