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/NCT05988632</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00000134</org_study_id>
      <nct_id>NCT05988632</nct_id>
    </id_info>
    <brief_title>Intranasal Insulin for Treatment of Alcohol Use Disorder</brief_title>
    <acronym>ITA</acronym>
    <official_title>Intranasal Insulin for Treatment of Alcohol Use Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brown University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Brown 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized controlled trial (RCT), within-subject, crossover, double-blind,&#xD;
        placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD)&#xD;
        (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting,&#xD;
        randomized participants will receive a single dose of IN insulin (80IU) or an IN matched&#xD;
        placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an&#xD;
        alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content&#xD;
        (BrAC) to 0.08g/dL.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with&#xD;
        AUD include the following:&#xD;
  &#xD;
        AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a&#xD;
        pharmacological intervention for AUD. The data collected in this aim will monitor possible&#xD;
        adverse events and yield qualitative and quantitative data to finalize the feasibility and&#xD;
        acceptability of IN insulin as an AUD pharmacotherapy.&#xD;
  &#xD;
        Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when&#xD;
        administered with alcohol. The investigators will use a battery of&#xD;
        physiological/psychological assessments that measures potential adverse events, alcohol&#xD;
        subjective response and alcohol pharmacokinetics endpoints.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 20, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>intranasal adverse events</measure>
      <time_frame>From baseline to post-treatment (1 day)</time_frame>
      <description>Adverse event reported during the drug administration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>insulin alcohol interaction</measure>
      <time_frame>From baseline to post-treatment (1 day)</time_frame>
      <description>Adverse event reported during the alcohol administration</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <arm_group>
      <arm_group_label>Insulin, Then Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo, Then Insulin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Regular Human Insulin then Placebo</intervention_name>
      <description>Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)</description>
      <arm_group_label>Insulin, Then Placebo</arm_group_label>
      <other_name>Novolin R</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo then Regular Human Insulin</intervention_name>
      <description>Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)</description>
      <arm_group_label>Placebo, Then Insulin</arm_group_label>
      <other_name>Novolin R</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥21 years&#xD;
  &#xD;
                 -  meet any DSM-5 criteria score for AUD&#xD;
  &#xD;
                 -  Individuals who, in the last month, have consumed at least the same amount of&#xD;
                    alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC&#xD;
                    levels of 0.08g/dl, ~two drinks in one occasion)&#xD;
  &#xD;
                 -  BrAC=0.00g/dL at each visit&#xD;
  &#xD;
                 -  good health as confirmed by medical history, physical examination and lab tests&#xD;
  &#xD;
                 -  willing to adhere to the study procedures&#xD;
  &#xD;
                 -  understand informed consent and questionnaires in English at an 8th grade level&#xD;
  &#xD;
                 -  willing to have glucose monitored by finger stick during the laboratory&#xD;
                    procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • female identifying who are breastfeeding or pregnant (assessed by a urine screen)&#xD;
  &#xD;
                 -  individuals with diabetes&#xD;
  &#xD;
                 -  history of suicide attempts in the last three years&#xD;
  &#xD;
                 -  current diagnosis of other substance use disorder (other than nicotine or&#xD;
                    cannabis)&#xD;
  &#xD;
                 -  use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by&#xD;
                    urine tox screen)&#xD;
  &#xD;
                 -  cannabis intoxication (by clinical assessments)&#xD;
  &#xD;
                 -  use of medications that may interact with insulin and alcohol (by Micromedex&#xD;
                    database)&#xD;
  &#xD;
                 -  hypersensitivity to insulin&#xD;
  &#xD;
                 -  any nasal disease/congestion that may interfere with intranasal drug absorption;&#xD;
  &#xD;
                 -  baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose&#xD;
                    &gt;200mg/dL) (by finger stick)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Carolina L Haass-Koffler</last_name>
      <phone>4155191385</phone>
      <email>carolina_haass-koffler@brown.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brown University</investigator_affiliation>
      <investigator_full_name>Carolina Haass-Koffler</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>Alcoholism</mesh_term>
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
      <mesh_term>Insulin, Globin Zinc</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05988632
  org study id: STUDY00000134
  nct id: NCT05988632
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a randomized controlled trial (RCT), within-subject, crossover, double-blind,
        placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD)
        (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting,
        randomized participants will receive a single dose of IN insulin (80IU) or an IN matched
        placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an
        alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content
        (BrAC) to 0.08g/dL.
  Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with
        AUD include the following:
  
        AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a
        pharmacological intervention for AUD. The data collected in this aim will monitor possible
        adverse events and yield qualitative and quantitative data to finalize the feasibility and
        acceptability of IN insulin as an AUD pharmacotherapy.
  
        Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when
        administered with alcohol. The investigators will use a battery of
        physiological/psychological assessments that measures potential adverse events, alcohol
        subjective response and alcohol pharmacokinetics endpoints.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: intranasal adverse events
  time frame: From baseline to post-treatment (1 day)
  description: Adverse event reported during the drug administration
  measure: insulin alcohol interaction
  time frame: From baseline to post-treatment (1 day)
  description: Adverse event reported during the alcohol administration
  arm group label: Insulin, Then Placebo
  arm group type: Experimental
  description: There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.
  arm group label: Placebo, Then Insulin
  arm group type: Experimental
  description: There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.
  intervention type: Drug
  intervention name: Regular Human Insulin then Placebo
  description: Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
  arm group label: Insulin, Then Placebo
  other name: Novolin R
  intervention type: Drug
  intervention name: Placebo then Regular Human Insulin
  description: Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
  arm group label: Placebo, Then Insulin
  other name: Novolin R
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Carolina L Haass-Koffler
  phone: 4155191385
  email: carolina_haass-koffler@brown.edu
  responsible party type: Principal Investigator
  investigator affiliation: Brown University
  investigator full name: Carolina Haass-Koffler
  investigator title: Associate Professor
  mesh term: Alcoholism
  mesh term: Alcohol Drinking
  mesh term: Insulin
  mesh term: Insulin, Globin Zinc
  sharing ipd: No