<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/NCT03293017</url>
  </required_header>
  <id_info>
    <org_study_id>22112015</org_study_id>
    <nct_id>NCT03293017</nct_id>
  </id_info>
  <brief_title>Baclofen in Managing Acute Alcohol Withdrawal</brief_title>
  <official_title>Baclofen Bij de Behandeling Van Acute Alcoholontwenning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</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 study goal is to investigate whether administration of oral baclofen forms an adequate&#xD;
      treatment option in the management of acute alcohol withdrawal. The investigators will&#xD;
      compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized&#xD;
      controlled trial including patients receiving symptom triggered diazepam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The conducted study will be randomized and single-blind (patients). After signing informed&#xD;
      consent, the participants will be randomized in one of three groups: - placebo - baclofen 30&#xD;
      mg/day - baclofen 60 mg/day. The participants will be given a first administration after&#xD;
      which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score&#xD;
      triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is&#xD;
      the number of participants who received additional diazepam during these 7 days. The&#xD;
      secondary outcome measure is the amount of diazepam received per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need for additional diazepam</measure>
    <time_frame>Measured 7 days after the start of alcohol withdrawal</time_frame>
    <description>Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of additional diazepam needed</measure>
    <time_frame>Measured 7 days after the start of alcohol withdrawal</time_frame>
    <description>The difference between the total dosages of additional diazepam needed between the three study arms</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Alcohol Withdrawal</condition>
  <arm_group>
    <arm_group_label>Baclofen 30 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>baclofen 30 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baclofen 60 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam 10 MG</intervention_name>
    <description>If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.</description>
    <arm_group_label>Baclofen 30 mg/day</arm_group_label>
    <arm_group_label>Baclofen 60 mg/day</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen 30mg</intervention_name>
    <description>Baclofen 30 mg/day given over three gifts daily</description>
    <arm_group_label>Baclofen 30 mg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen 60mg</intervention_name>
    <description>Baclofen 60 mg/day given over three gifts daily</description>
    <arm_group_label>Baclofen 60 mg/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.&#xD;
&#xD;
          -  Be able to sign informed consent.&#xD;
&#xD;
          -  Be male/female aged 18-60&#xD;
&#xD;
          -  Primary diagnosis of alcohol use disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breastfeeding.&#xD;
&#xD;
          -  Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.&#xD;
&#xD;
          -  Psychosis, confusion and acute mania.&#xD;
&#xD;
          -  Parkinson's disease.&#xD;
&#xD;
          -  Use of tricyclic antidepressants.&#xD;
&#xD;
          -  Use of opioids.&#xD;
&#xD;
          -  Known baclofen or benzodiazepine sensitivity or allergy.&#xD;
&#xD;
          -  Unable to take oral medication.&#xD;
&#xD;
          -  epidermal growth factor receptor (EGFR) &lt; 60 (blood samples are routinely performed at&#xD;
             intake).&#xD;
&#xD;
          -  Prior diagnosis of epilepsy.&#xD;
&#xD;
          -  Lactose intolerance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frieda Matthys, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cleo L Crunelle, PhD</last_name>
    <email>nacstudie@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sami Jegham, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Brussels</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cleo L Crunelle, PhD</last_name>
      <email>nacstudie@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 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>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diazepam</mesh_term>
    <mesh_term>Baclofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293017
org study id: 22112015
nct id: NCT03293017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study goal is to investigate whether administration of oral baclofen forms an adequate
      treatment option in the management of acute alcohol withdrawal. The investigators will
      compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized
      controlled trial including patients receiving symptom triggered diazepam.
The conducted study will be randomized and single-blind (patients). After signing informed
      consent, the participants will be randomized in one of three groups: - placebo - baclofen 30
      mg/day - baclofen 60 mg/day. The participants will be given a first administration after
      which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score
      triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is
      the number of participants who received additional diazepam during these 7 days. The
      secondary outcome measure is the amount of diazepam received per group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Need for additional diazepam
time frame: Measured 7 days after the start of alcohol withdrawal
description: Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal
measure: Dosage of additional diazepam needed
time frame: Measured 7 days after the start of alcohol withdrawal
description: The difference between the total dosages of additional diazepam needed between the three study arms
arm group label: Baclofen 30 mg/day
arm group type: Experimental
description: baclofen 30 mg/day
arm group label: Baclofen 60 mg/day
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Diazepam 10 MG
description: If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.
arm group label: Baclofen 30 mg/day
arm group label: Baclofen 60 mg/day
arm group label: Placebo
intervention type: Drug
intervention name: Baclofen 30mg
description: Baclofen 30 mg/day given over three gifts daily
arm group label: Baclofen 30 mg/day
intervention type: Drug
intervention name: Baclofen 60mg
description: Baclofen 60 mg/day given over three gifts daily
arm group label: Baclofen 60 mg/day
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Frieda Matthys, PhD
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
last name: Cleo L Crunelle, PhD
email: nacstudie@gmail.com
last name: Sami Jegham, MD
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Diazepam
mesh term: Baclofen
sharing ipd: Undecided