<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/NCT02242955</url>
  </required_header>
  <id_info>
    <org_study_id>2011_44</org_study_id>
    <secondary_id>2012-003336-23</secondary_id>
    <nct_id>NCT02242955</nct_id>
  </id_info>
  <brief_title>Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse</brief_title>
  <acronym>DIAMA</acronym>
  <official_title>Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol&#xD;
      withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference&#xD;
      medication for preventing or treating AWS. The recommended average diazepam treatment&#xD;
      duration is usually around one week, and this duration is generally not considered to impact&#xD;
      the subsequent relapse rate in alcohol drinking.&#xD;
&#xD;
      However, several previous studies have found that patients experienced frequent anxious&#xD;
      symptoms during the weeks following detoxification. Such symptoms may foster early relapse in&#xD;
      alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late&#xD;
      withdrawal symptoms.&#xD;
&#xD;
      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one&#xD;
      month can significantly reduce the cumulated relapse rate in alcohol drinking over the three&#xD;
      following months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  inclusion at Day 5 of the outpatient alcohol detoxification procedure&#xD;
&#xD;
        -  randomization in two arms: 1) &quot;10 day - diazepam&quot;; and 2) &quot;30 day - diazepam&quot;&#xD;
&#xD;
        -  tapering of diazepam over the 10 days following the beginning of the detoxification&#xD;
           procedure in the first arm; tapering of diazepam over the 30 days following the&#xD;
           beginning of the detoxification procedure in the second arm.&#xD;
&#xD;
        -  3-month-long follow-up after detoxification. Objective of maintaining abstinence from&#xD;
           alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support&#xD;
           based on the BRENDA model.&#xD;
&#xD;
        -  Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back&#xD;
           method.&#xD;
&#xD;
        -  Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait&#xD;
           Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and&#xD;
           90 (final assessment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of relapse in alcohol drinking</measure>
    <time_frame>at 3 months</time_frame>
    <description>Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>Over the first month, at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of relapse in heavy drinking</measure>
    <time_frame>at 1 month; at 3 months</time_frame>
    <description>Proportion of patients who will have reported at least one heavy drinking day, i.e., ≥ 50 g of alcohol in a day, over the first month and the three month following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of drinking days/heavy drinking days</measure>
    <time_frame>over the first month, at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of self-reported anxiety</measure>
    <time_frame>at 1 month; at 3 months</time_frame>
    <description>Score of self-reported anxiety using the State-Trait Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of clinician-assessed anxiety</measure>
    <time_frame>at 1 month; at 3 months</time_frame>
    <description>Score of anxiety using the Hamilton Anxiety Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of alcohol craving</measure>
    <time_frame>at 1 month; at 3 months</time_frame>
    <description>Level of alcohol craving using the Obsessive-Compulsive Drinking Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average weekly alcohol consumption</measure>
    <time_frame>at 1 month; at 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>AD = &quot;as-usual diazepam&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PD = &quot;prolonged diazepam&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diazepam will be slowly tapered to be stopped at day 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam</intervention_name>
    <description>40 mg per day.</description>
    <arm_group_label>AD = &quot;as-usual diazepam&quot;</arm_group_label>
    <arm_group_label>PD = &quot;prolonged diazepam&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-IV-Tr criteria for alcohol dependence&#xD;
&#xD;
          -  Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for outpatient detoxification&#xD;
&#xD;
          -  occurrence of delirium tremens or seizures during the pre-inclusion period&#xD;
&#xD;
          -  contraindication for using diazepam&#xD;
&#xD;
          -  any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year&#xD;
             (except from tobacco)&#xD;
&#xD;
          -  concurrent axis-I psychiatric disorder&#xD;
&#xD;
          -  concurrent neurological pathology or cognitive impairment&#xD;
&#xD;
          -  concurrent social risk, i.e., homelessness or social isolation&#xD;
&#xD;
          -  liver failure, cancer, or significant breathing disorder&#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>Benjamin ROLLAND, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Lille (CHU Lille), France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Addiction Medicine</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Outpatient Addiction Center &quot;CSAPA - Le Pari&quot;</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol-dependence</keyword>
  <keyword>Relapse</keyword>
  <keyword>Detoxification</keyword>
  <keyword>Diazepam</keyword>
  <keyword>Benzodiazepines</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <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>
  </intervention_browse>
  <!-- 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/NCT02242955
org study id: 2011_44
secondary id: 2012-003336-23
nct id: NCT02242955
lead sponsor: 
has dmc: Yes
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol
      withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference
      medication for preventing or treating AWS. The recommended average diazepam treatment
      duration is usually around one week, and this duration is generally not considered to impact
      the subsequent relapse rate in alcohol drinking.

      However, several previous studies have found that patients experienced frequent anxious
      symptoms during the weeks following detoxification. Such symptoms may foster early relapse in
      alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late
      withdrawal symptoms.

      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one
      month can significantly reduce the cumulated relapse rate in alcohol drinking over the three
      following months.
-  inclusion at Day 5 of the outpatient alcohol detoxification procedure

        -  randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"

        -  tapering of diazepam over the 10 days following the beginning of the detoxification
           procedure in the first arm; tapering of diazepam over the 30 days following the
           beginning of the detoxification procedure in the second arm.

        -  3-month-long follow-up after detoxification. Objective of maintaining abstinence from
           alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support
           based on the BRENDA model.

        -  Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back
           method.

        -  Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait
           Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and
           90 (final assessment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of relapse in alcohol drinking
time frame: at 3 months
description: Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
measure: Occurrence of adverse events
time frame: Over the first month, at 3 months
measure: Rate of relapse in heavy drinking
time frame: at 1 month; at 3 months
description: Proportion of patients who will have reported at least one heavy drinking day, i.e., ≥ 50 g of alcohol in a day, over the first month and the three month following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
measure: Ratio of drinking days/heavy drinking days
time frame: over the first month, at 3 months
measure: Level of self-reported anxiety
time frame: at 1 month; at 3 months
description: Score of self-reported anxiety using the State-Trait Anxiety Inventory
measure: Level of clinician-assessed anxiety
time frame: at 1 month; at 3 months
description: Score of anxiety using the Hamilton Anxiety Rating Scale
measure: Level of alcohol craving
time frame: at 1 month; at 3 months
description: Level of alcohol craving using the Obsessive-Compulsive Drinking Scale
measure: Average weekly alcohol consumption
time frame: at 1 month; at 3 months
arm group label: AD = "as-usual diazepam"
arm group type: Active Comparator
description: Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).
arm group label: PD = "prolonged diazepam"
arm group type: Experimental
description: Diazepam will be slowly tapered to be stopped at day 30
intervention type: Drug
intervention name: Diazepam
description: 40 mg per day.
arm group label: AD = "as-usual diazepam"
arm group label: PD = "prolonged diazepam"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Benjamin ROLLAND, MD, PhD
role: Principal Investigator
affiliation: University Hospital of Lille (CHU Lille), France
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Recurrence
mesh term: Alcoholism
mesh term: Diazepam