<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/NCT03273283</url>
  </required_header>
  <id_info>
    <org_study_id>PPAU</org_study_id>
    <nct_id>NCT03273283</nct_id>
  </id_info>
  <brief_title>Feasibility and Effectiveness of a Specialized Brief Intervention for Hazardous Drinkers in an Emergency Department.</brief_title>
  <acronym>PPAU</acronym>
  <official_title>Prevenció Dels Problemes Relacionats Amb Alcohol a urgències.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      Alcohol use and its consequences represent an important public health problem. As well as&#xD;
      alcohol dependence, hazardous drinking also contributes to a high burden in terms of&#xD;
      morbidity and mortality. To improve these patients' prognosis and decrease associated social&#xD;
      and health care costs, it is necessary to increase early detection, intervention and&#xD;
      treatment for these problems. For these reasons, SBIRT programmes (Screening Brief&#xD;
      Intervention and Referral to Treatment) have been developed, evaluated and shown to be&#xD;
      effective, particularly in primary care and general practice. Nevertheless, effectiveness of&#xD;
      SBIRT in emergency departments (ED) has not been clearly established.&#xD;
&#xD;
      The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the&#xD;
      ED of a tertiary hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators conducted a randomized controlled trial to study the feasibility and&#xD;
      efficacy of an SBIRT programme for hazardous drinkers presenting in an ED. All patients older&#xD;
      than 18 years old attending the emergency department were potentially eligible. Cognitively&#xD;
      impaired or medically unstable patients were excluded. Patients seeking treatment for alcohol&#xD;
      use were also excluded. Patients were randomized to two groups, with the control group&#xD;
      receiving two leaflets - one regarding alcohol use, and the other giving information about&#xD;
      the study protocol. The intervention group received the same leaflets as well as a brief&#xD;
      motivational intervention on alcohol use; and, where appropriate, a referral to specialised&#xD;
      treatment. The primary outcomes were the proportion of hazardous drinkers measured by AUDIT-C&#xD;
      scale and the proportion of patients attending specialised treatment at 1.5 and 4.5 months&#xD;
      and 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Proportion of Risky Drinkers Measured by AUDIT-C</measure>
    <time_frame>6 weeks</time_frame>
    <description>We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.&#xD;
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Patients Attending to Specialized Treatment</measure>
    <time_frame>6 weeks</time_frame>
    <description>Proportion of patients that initate specialized treatment to reduce alcohol use</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Informative leaflets regarding alcohol use</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Intervention</intervention_name>
    <description>Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Referral to treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged 18 or older attending to the emergency department were potentially&#xD;
             eligible patients&#xD;
&#xD;
          -  Patients with an AUDIT-C score higher than 6 points for men and 5 for woman were&#xD;
             invited to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Patients explicitly demanding alcohol treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>April 20, 2020</results_first_submitted>
  <results_first_submitted_qc>May 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 15, 2020</results_first_posted>
  <last_update_submitted>May 14, 2020</last_update_submitted>
  <last_update_submitted_qc>May 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Antoni Gual</investigator_full_name>
    <investigator_title>Head of the Addiction Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is nno plan, but we have already shared and will continue sharing them</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Since de beginning and for 5 years</ipd_time_frame>
    <ipd_access_criteria>For scientific purposes</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03273283/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.&#xD;
Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Informative leaflets regarding alcohol use</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>At baseline, participants' demographic and enrollment-related characteristics were compared across treatment conditions using t- and chi-square tests according to the nature of each variable.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.&#xD;
Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Informative leaflets regarding alcohol use</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="99"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.6" spread="16.2"/>
                    <measurement group_id="B2" value="44" spread="17.1"/>
                    <measurement group_id="B3" value="42.81" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol related presenting condition</title>
          <description>Those patients attended on ED for a condition directly related to their alcohol consumption, such as alcohol intoxications, accidents, liver diseases...</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Risky Drinkers Measured by AUDIT-C</title>
        <description>We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.&#xD;
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.&#xD;
Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Informative leaflets regarding alcohol use</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Risky Drinkers Measured by AUDIT-C</title>
          <description>We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.&#xD;
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Attending to Specialized Treatment</title>
        <description>Proportion of patients that initate specialized treatment to reduce alcohol use</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.&#xD;
Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Informative leaflets regarding alcohol use</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Attending to Specialized Treatment</title>
          <description>Proportion of patients that initate specialized treatment to reduce alcohol use</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>no different definition</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.&#xD;
Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Informative leaflets regarding alcohol use</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pol Bruguera Soler</name_or_title>
      <organization>Hospital Clínic de Barcelona</organization>
      <phone>628162567</phone>
      <email>pbruguer@clinic.cat</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03273283
org study id: PPAU
nct id: NCT03273283
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Alcohol use and its consequences represent an important public health problem. As well as
      alcohol dependence, hazardous drinking also contributes to a high burden in terms of
      morbidity and mortality. To improve these patients' prognosis and decrease associated social
      and health care costs, it is necessary to increase early detection, intervention and
      treatment for these problems. For these reasons, SBIRT programmes (Screening Brief
      Intervention and Referral to Treatment) have been developed, evaluated and shown to be
      effective, particularly in primary care and general practice. Nevertheless, effectiveness of
      SBIRT in emergency departments (ED) has not been clearly established.

      The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the
      ED of a tertiary hospital.
The investigators conducted a randomized controlled trial to study the feasibility and
      efficacy of an SBIRT programme for hazardous drinkers presenting in an ED. All patients older
      than 18 years old attending the emergency department were potentially eligible. Cognitively
      impaired or medically unstable patients were excluded. Patients seeking treatment for alcohol
      use were also excluded. Patients were randomized to two groups, with the control group
      receiving two leaflets - one regarding alcohol use, and the other giving information about
      the study protocol. The intervention group received the same leaflets as well as a brief
      motivational intervention on alcohol use; and, where appropriate, a referral to specialised
      treatment. The primary outcomes were the proportion of hazardous drinkers measured by AUDIT-C
      scale and the proportion of patients attending specialised treatment at 1.5 and 4.5 months
      and 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Risky Drinkers Measured by AUDIT-C
time frame: 6 weeks
description: We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.
measure: Proportion of Patients Attending to Specialized Treatment
time frame: 6 weeks
description: Proportion of patients that initate specialized treatment to reduce alcohol use
arm group label: Intervention
arm group type: Experimental
description: Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.
arm group label: Control
arm group type: No Intervention
description: Informative leaflets regarding alcohol use
intervention type: Behavioral
intervention name: Brief Intervention
description: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.
arm group label: Intervention
other name: Referral to treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Antoni Gual
investigator title: Head of the Addiction Unit
mesh term: Alcohol Drinking
sharing ipd: Yes
ipd description: There is nno plan, but we have already shared and will continue sharing them
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Since de beginning and for 5 years
ipd access criteria: For scientific purposes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 