<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/NCT03279562</url>
  </required_header>
  <id_info>
    <org_study_id>1610018492</org_study_id>
    <nct_id>NCT03279562</nct_id>
  </id_info>
  <brief_title>Patient Driven Recovery With Nalmefene and Coaching</brief_title>
  <official_title>Patient Driven Recovery With Nalmefene and Coaching</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Pavlov State Medical University in St. Petersburg, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we&#xD;
      are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety,&#xD;
      feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use&#xD;
      disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented&#xD;
      drug counseling). The proposed pilot study will also be used to further develop and refine&#xD;
      the recovery coaching/counseling intervention and to train additional cadre of clinicians and&#xD;
      researchers in St. Petersburg, Russia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims and hypotheses of the proposed study are as follows:&#xD;
&#xD;
      Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy&#xD;
      of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching&#xD;
      for rehabilitation of detoxified opioid dependent individuals in Russia.&#xD;
&#xD;
      Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention&#xD;
      and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pilot, open label, non-randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of abstinence from illicit opioids</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Days of abstinence from illicit opioids, based on urine tests and self-report</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment retention</measure>
    <time_frame>6 months</time_frame>
    <description>Duration of treatment participation, number of days in treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Harmful; Use, Alcohol</condition>
  <arm_group>
    <arm_group_label>Nalmefene and recovery coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nalmefene prescribed for daily ingestion during the first 3 months of treatment; patients who maintain a successful recovery during the first 3 months of treatment will be offered an option to take Nalmefene on as needed basis, always before encountering situations or circumstances with heightened risk of alcohol or opioid use</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalmefene</intervention_name>
    <description>Educational and behaviorally oriented drug counseling</description>
    <arm_group_label>Nalmefene and recovery coaching</arm_group_label>
    <other_name>Recovery coaching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals who meet DSM IV criteria for opioid dependence, who use street methadone&#xD;
             (the main, most frequently used street opioid in Saint Petersburg, Russia) by&#xD;
             intravenous injections, who have a history of alcohol use disorder or high risk&#xD;
             alcohol use, who successfully completed inpatient, medically supervised&#xD;
             detoxification, who are seeking a rehabilitation treatment following detoxification,&#xD;
             and who pass a naloxone challenge (indicating the current lack of physiological&#xD;
             dependence on opioids)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current suicide or homicide risk; current psychotic disorder or major depression;&#xD;
             inability to understand the consent form or assessments; pregnancy; acute medical&#xD;
             conditions requiring medical treatment, co-occurring dependence/abuse of other drugs&#xD;
             including alcohol, benzodiazepines, or amphetamine type stimulants (ATS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yale University, Department</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nalmefene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03279562
org study id: 1610018492
nct id: NCT03279562
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we
      are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety,
      feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use
      disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented
      drug counseling). The proposed pilot study will also be used to further develop and refine
      the recovery coaching/counseling intervention and to train additional cadre of clinicians and
      researchers in St. Petersburg, Russia.
The specific aims and hypotheses of the proposed study are as follows:

      Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy
      of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching
      for rehabilitation of detoxified opioid dependent individuals in Russia.

      Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention
      and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot, open label, non-randomized clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of abstinence from illicit opioids
time frame: Past 30 days
description: Days of abstinence from illicit opioids, based on urine tests and self-report
measure: Treatment retention
time frame: 6 months
description: Duration of treatment participation, number of days in treatment
arm group label: Nalmefene and recovery coaching
arm group type: Experimental
description: Nalmefene prescribed for daily ingestion during the first 3 months of treatment; patients who maintain a successful recovery during the first 3 months of treatment will be offered an option to take Nalmefene on as needed basis, always before encountering situations or circumstances with heightened risk of alcohol or opioid use
intervention type: Drug
intervention name: Nalmefene
description: Educational and behaviorally oriented drug counseling
arm group label: Nalmefene and recovery coaching
other name: Recovery coaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Nalmefene
sharing ipd: No