<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/NCT04405414</url>
  </required_header>
  <id_info>
    <org_study_id>RC19_0405</org_study_id>
    <nct_id>NCT04405414</nct_id>
  </id_info>
  <brief_title>EffectS of CAnnabidiol in Patients: Evaluation</brief_title>
  <acronym>ESCAPE</acronym>
  <official_title>Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis,&#xD;
      is used in many over-the-counter products in France. Some painful patients or patients&#xD;
      suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are&#xD;
      no data available for patients in algology and addictology, particularly with regard to the&#xD;
      prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the&#xD;
      use of a substance with a therapeutic purpose but outside a medical framework and without&#xD;
      monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main&#xD;
      objective of the study is therefore to assess the prevalence of CBD users in algology and&#xD;
      addictology departments. Secondary objectives are to characterize the use of CBD as well as&#xD;
      the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive&#xD;
      substances use or current drug treatments and the drug liking of CBD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physicians from algology and addictology departments will propose the study to all patients&#xD;
      who meet the inclusion criteria during a medical consultation (in hospitalization or&#xD;
      ambulatory care). If the patient agrees to participate, the non-opposition will be collected&#xD;
      and the physician will complete a short form with sociodemographic data, medical history and&#xD;
      contact details of the patient.&#xD;
&#xD;
      The form will be transmitted securely to the research staff that will perform a unique&#xD;
      research evaluation face to face (when the patient is still hospitalized and available) or by&#xD;
      phone (when the patient is not available during hospitalization or no longer hospitalized or&#xD;
      in case of ambulatory care). The research evaluation includes data about the frequency and&#xD;
      the duration of the use of all substances (CBD included) in the last 12 months and the&#xD;
      frequency of current drug treatments. For patients with CBD use in the last 12 months,&#xD;
      additional data regarding the use of CBD will be collected: the form, the route of&#xD;
      administration, the effects sought and felt, the method of obtaining, the impact on other&#xD;
      drugs and/or substances use and the drug liking of CBD.&#xD;
&#xD;
      A descriptive analysis will be carried out. The CBD user group and the CBD non-user group&#xD;
      will be compared on all the variables collected. A multivariate analysis will be carried out&#xD;
      in order to identify factors associated to CBD use in algology and addictology patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2020</start_date>
  <completion_date type="Actual">July 26, 2021</completion_date>
  <primary_completion_date type="Actual">July 26, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of CBD users</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>For all patients included in the study, the use of CBD during the last 12 months (yes or no) will be collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of the use of CBD</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Prevalence of form, all effects sought and felt, method of obtaining and route of administration of CBD, frequency and duration of the use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of CBD users</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Prevalence of CBD users (use of CBD in the last 12 months) according to patients' characteristics: age categories, sex, employment status, medical history, other psychoactive substances use, current drug treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the use of CBD</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Proportion of CBD users who stopped, decreased, increased or initiated drug treatments in relation to the CBD use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CBD drug-liking</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Mean on Visual Analog Scale (VAS) on drug liking for CBD and frequency of substances or drug treatments that would be taken as alternatives in the absence of CBD</description>
  </secondary_outcome>
  <enrollment type="Actual">746</enrollment>
  <condition>Substance-Related Disorders</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Form</intervention_name>
    <description>Data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Physicians from algology and addictology departments will propose the study to all patients&#xD;
        who meet the inclusion criteria during a medical consultation (in hospitalization or&#xD;
        ambulatory care)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Patients for whom hospital specialists in algology or addictology have been requested&#xD;
             (for hospitalized or ambulatory cares) during the inclusion period.&#xD;
&#xD;
          -  Giving oral non opposition to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults under guardianship or curator&#xD;
&#xD;
          -  Patients unable to respond to the research evaluation (cerebral function disorder,&#xD;
             difficulty to understand, read or write French language).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <state>Loire-Atlantique</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cannabidiol</keyword>
  <keyword>prevalence</keyword>
  <keyword>epidemiology</keyword>
  <keyword>pain</keyword>
  <keyword>substance-related disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_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/NCT04405414
org study id: RC19_0405
nct id: NCT04405414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis,
      is used in many over-the-counter products in France. Some painful patients or patients
      suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are
      no data available for patients in algology and addictology, particularly with regard to the
      prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the
      use of a substance with a therapeutic purpose but outside a medical framework and without
      monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main
      objective of the study is therefore to assess the prevalence of CBD users in algology and
      addictology departments. Secondary objectives are to characterize the use of CBD as well as
      the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive
      substances use or current drug treatments and the drug liking of CBD.
Physicians from algology and addictology departments will propose the study to all patients
      who meet the inclusion criteria during a medical consultation (in hospitalization or
      ambulatory care). If the patient agrees to participate, the non-opposition will be collected
      and the physician will complete a short form with sociodemographic data, medical history and
      contact details of the patient.

      The form will be transmitted securely to the research staff that will perform a unique
      research evaluation face to face (when the patient is still hospitalized and available) or by
      phone (when the patient is not available during hospitalization or no longer hospitalized or
      in case of ambulatory care). The research evaluation includes data about the frequency and
      the duration of the use of all substances (CBD included) in the last 12 months and the
      frequency of current drug treatments. For patients with CBD use in the last 12 months,
      additional data regarding the use of CBD will be collected: the form, the route of
      administration, the effects sought and felt, the method of obtaining, the impact on other
      drugs and/or substances use and the drug liking of CBD.

      A descriptive analysis will be carried out. The CBD user group and the CBD non-user group
      will be compared on all the variables collected. A multivariate analysis will be carried out
      in order to identify factors associated to CBD use in algology and addictology patients.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of CBD users
time frame: through study completion, an average of 2 year
description: For all patients included in the study, the use of CBD during the last 12 months (yes or no) will be collected.
measure: Characterization of the use of CBD
time frame: through study completion, an average of 2 year
description: Prevalence of form, all effects sought and felt, method of obtaining and route of administration of CBD, frequency and duration of the use.
measure: Characterization of CBD users
time frame: through study completion, an average of 2 year
description: Prevalence of CBD users (use of CBD in the last 12 months) according to patients' characteristics: age categories, sex, employment status, medical history, other psychoactive substances use, current drug treatments.
measure: Impact of the use of CBD
time frame: through study completion, an average of 2 year
description: Proportion of CBD users who stopped, decreased, increased or initiated drug treatments in relation to the CBD use.
measure: CBD drug-liking
time frame: through study completion, an average of 2 year
description: Mean on Visual Analog Scale (VAS) on drug liking for CBD and frequency of substances or drug treatments that would be taken as alternatives in the absence of CBD
intervention type: Other
intervention name: Form
description: Data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Substance-Related Disorders