<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/NCT03254238</url>
  </required_header>
  <id_info>
    <org_study_id>2016-50</org_study_id>
    <nct_id>NCT03254238</nct_id>
  </id_info>
  <brief_title>Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior</brief_title>
  <acronym>MEGADOSE</acronym>
  <official_title>Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Prescription drug abuse is a major challenge in public health, in particular in countries&#xD;
      such as France, one of the main consumers of medication in Europe. A single source of&#xD;
      information is rarely sufficient to measure such a complex phenomenon. This project entitled&#xD;
      MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete&#xD;
      efficiently the available data from the addictovigilance centres allowing the health&#xD;
      authorities (French Drug Agency) to answer to the main general questions (What are the main&#xD;
      prescription drug abused in France? What are the national trends in prescription drug abuse?&#xD;
      What is the impact of a public health measure on prescription drug abuse). This project&#xD;
      constitutes the opportunity of &quot;extending&quot; the application of our tool (the DS method) on a&#xD;
      French national database with a minimal risk since this method has already been validated and&#xD;
      applied on different geographic areas, on different drugs and at different levels of&#xD;
      analysis. The project would also be integrated in routinely as a useful tool included in the&#xD;
      addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of&#xD;
      policy and practice interventions implemented by the French Drug Agency.&#xD;
&#xD;
      The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM&#xD;
      related to drug misuse in particular: development and identification of systems and tools&#xD;
      able to detect earlier misuse phenomenon; analysis of the impact of communications,&#xD;
      guidelines, decisions to health authorities and patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medicines such as analgesics, opioids substitution drugs, sedatives, hypnotics are&#xD;
      increasingly being misuse to induce psychoactive effects or to alter the effects of other&#xD;
      consumed drugs, potentially resulting in abuse and dependence (24). Awareness of medicine&#xD;
      misuse, especially prescription drugs misuse has been increasing in the past few years and&#xD;
      organizations such as the United Nation's International Narcotics Control Board predict that&#xD;
      worldwide misuse of prescription drugs will exceed illicit drug use. A major potential part&#xD;
      of psychoactive drug misuse is related to drug abuse. Assessment of misuse, abuse and&#xD;
      diversion of prescription drugs must address its occult nature and involves fundamentally&#xD;
      different monitoring methods compared to other pharmaceutical products. Current best practice&#xD;
      is to use multiple detection systems to assess misuse, abuse, and diversion of CNS active&#xD;
      drugs by various populations in a timely, sensitive and specific manner (20). In order to&#xD;
      detect earlier the prescription drug abuse related to misuse, the investigators have&#xD;
      developed a specific method, the doctor shopping method, at the regional level. Doctor&#xD;
      shopping is a well-known behavior defined as obtaining prescriptions from several physicians&#xD;
      for the same medication at the same time. By cumulating the prescriptions of different&#xD;
      physicians during the same period of time, doctor shopping enables patients to be delivered a&#xD;
      daily dose superior to that prescribed by each physician on an individual basis. Doctor&#xD;
      shopping behavior is regarded as not only a means of obtaining high-dose prescriptions but as&#xD;
      the principal method of diversion of prescription medications to street markets.&#xD;
&#xD;
      Using health Insurance Database, the investigators have developed and validated a specific&#xD;
      method &quot;the doctor shopping method&quot; providing two indicators: the DSI (Doctor Shopping&#xD;
      Indicator expressed in %) and the DSQ (Doctor Shopping Quantity expressed in DDD), reflecting&#xD;
      respectively the risk of abuse and the extent of abuse. This previous large work, based along&#xD;
      ten years of development and validation through several different studies, has i) been always&#xD;
      performed at the regional level on SNIIR-AM (several French areas - Paca Corse, Rhône Alpes,&#xD;
      Midi Pyrenées), ii) focused on one product (buprenorphine, clonazepam, methylphenidate) or on&#xD;
      one pharmacological class (opioids, benzodiazepines) iii) measured the impact of national&#xD;
      prescription monitoring programme (buprenorphine). More recently the investigators have&#xD;
      performed a global overview of the extent and risk of abuse of more than 100 psychoactive&#xD;
      medications among 11.7 million inhabitants according the doctor shopping method, used as a&#xD;
      proxy of drug abuse. Based on this experience, and because there is a need to measure&#xD;
      prescription drug abuse, to understand trends over the time and to compare abuse of one&#xD;
      product to another, the aim of this project is to provide an up-to-date and nationally&#xD;
      consolidated estimation of the risk and the extent of abuse associated with more of 100&#xD;
      psychoactive drugs in the French population, using doctor shopping method on National&#xD;
      SNIIR-AM, covering the entire French population (65 million inhabitants). To increase the&#xD;
      accuracy of its estimation and its description, the study will take into account relevant&#xD;
      factors and determinants of drugs abuse such as i) formulation (dosage, extended or immediate&#xD;
      release, route of administration) ii) geographical level iii) time factor (trends analysis&#xD;
      between 2010 and 2015).&#xD;
&#xD;
      Prescription drug abuse is a major challenge in public health, in particular in countries&#xD;
      such as France, one of the main consumers of psychoactive medications in Europe. A single&#xD;
      source of information is rarely sufficient to measure such a complex phenomenon. This project&#xD;
      entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may&#xD;
      complete efficiently the available data from the addictovigilance centres allowing the health&#xD;
      authorities (French Drug Agency) to answer to the main general questions (What are the main&#xD;
      prescription drug abused in France? What are the national trends in prescription drug abuse?&#xD;
      What is the impact of a public health measures on prescription drug abuse).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>psychoactive drug misuse</measure>
    <time_frame>2 years</time_frame>
    <description>the doctor shopping method,to assess medication availability and the extent and risk of abuse of all psychoactive reimbursed drugs at a national level according to the doctor shopping method.&#xD;
All psychoactive drugs will be ranked according to their DSQ (used as a proxy of the extent of abuse) and their DSI (used as a proxy of abuse potential</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000000</enrollment>
  <condition>Misuse</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior</intervention_name>
    <description>development and identification of systems and tools able to detect earlier misuse phenomenon</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population is the whole French population. The SNIIR-AM will be used as the&#xD;
        source population. The SNIIR-AM (Systeme National d'Information Inter-Régime de l'Assurance&#xD;
        Maladie) is the information system of the French National Health Insurance Scheme,&#xD;
        containing individualized, anonymous, and exhaustive data on all health spending&#xD;
        reimbursements of the overall French insured population (almost 65 million inhabitants).&#xD;
&#xD;
        The information contained in this database covers the health care services reimbursed&#xD;
        including:&#xD;
&#xD;
          -  Characteristics of medication dispensed (name, formulation, dates of prescription,&#xD;
             date of dispensing, quantity dispensed and cost)&#xD;
&#xD;
          -  Patients characteristics including age, gender, area of residence, type of&#xD;
             affiliation, dependency on the universal health care coverage or CMU (Couverture&#xD;
             Médicale Universelle Complémentaire, CMUC, which is attributed to the unemployed and&#xD;
             low income insurees, and which can be used as a proxy of the income level),&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients registered in the SNIIR-AM with at least one reimbursement of psychoactive&#xD;
             drugs during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  French population not benefiting from social security&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle Desalbres</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joelle MICALLEF</last_name>
    <phone>04 91 38 75 63</phone>
    <email>joelle.micallef@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joelle MICALLEF</last_name>
      <phone>04 91 38 75 63</phone>
      <email>joelle.micallef@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03254238
org study id: 2016-50
nct id: NCT03254238
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prescription drug abuse is a major challenge in public health, in particular in countries
      such as France, one of the main consumers of medication in Europe. A single source of
      information is rarely sufficient to measure such a complex phenomenon. This project entitled
      MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete
      efficiently the available data from the addictovigilance centres allowing the health
      authorities (French Drug Agency) to answer to the main general questions (What are the main
      prescription drug abused in France? What are the national trends in prescription drug abuse?
      What is the impact of a public health measure on prescription drug abuse). This project
      constitutes the opportunity of "extending" the application of our tool (the DS method) on a
      French national database with a minimal risk since this method has already been validated and
      applied on different geographic areas, on different drugs and at different levels of
      analysis. The project would also be integrated in routinely as a useful tool included in the
      addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of
      policy and practice interventions implemented by the French Drug Agency.

      The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM
      related to drug misuse in particular: development and identification of systems and tools
      able to detect earlier misuse phenomenon; analysis of the impact of communications,
      guidelines, decisions to health authorities and patients
Medicines such as analgesics, opioids substitution drugs, sedatives, hypnotics are
      increasingly being misuse to induce psychoactive effects or to alter the effects of other
      consumed drugs, potentially resulting in abuse and dependence (24). Awareness of medicine
      misuse, especially prescription drugs misuse has been increasing in the past few years and
      organizations such as the United Nation's International Narcotics Control Board predict that
      worldwide misuse of prescription drugs will exceed illicit drug use. A major potential part
      of psychoactive drug misuse is related to drug abuse. Assessment of misuse, abuse and
      diversion of prescription drugs must address its occult nature and involves fundamentally
      different monitoring methods compared to other pharmaceutical products. Current best practice
      is to use multiple detection systems to assess misuse, abuse, and diversion of CNS active
      drugs by various populations in a timely, sensitive and specific manner (20). In order to
      detect earlier the prescription drug abuse related to misuse, the investigators have
      developed a specific method, the doctor shopping method, at the regional level. Doctor
      shopping is a well-known behavior defined as obtaining prescriptions from several physicians
      for the same medication at the same time. By cumulating the prescriptions of different
      physicians during the same period of time, doctor shopping enables patients to be delivered a
      daily dose superior to that prescribed by each physician on an individual basis. Doctor
      shopping behavior is regarded as not only a means of obtaining high-dose prescriptions but as
      the principal method of diversion of prescription medications to street markets.

      Using health Insurance Database, the investigators have developed and validated a specific
      method "the doctor shopping method" providing two indicators: the DSI (Doctor Shopping
      Indicator expressed in %) and the DSQ (Doctor Shopping Quantity expressed in DDD), reflecting
      respectively the risk of abuse and the extent of abuse. This previous large work, based along
      ten years of development and validation through several different studies, has i) been always
      performed at the regional level on SNIIR-AM (several French areas - Paca Corse, Rhône Alpes,
      Midi Pyrenées), ii) focused on one product (buprenorphine, clonazepam, methylphenidate) or on
      one pharmacological class (opioids, benzodiazepines) iii) measured the impact of national
      prescription monitoring programme (buprenorphine). More recently the investigators have
      performed a global overview of the extent and risk of abuse of more than 100 psychoactive
      medications among 11.7 million inhabitants according the doctor shopping method, used as a
      proxy of drug abuse. Based on this experience, and because there is a need to measure
      prescription drug abuse, to understand trends over the time and to compare abuse of one
      product to another, the aim of this project is to provide an up-to-date and nationally
      consolidated estimation of the risk and the extent of abuse associated with more of 100
      psychoactive drugs in the French population, using doctor shopping method on National
      SNIIR-AM, covering the entire French population (65 million inhabitants). To increase the
      accuracy of its estimation and its description, the study will take into account relevant
      factors and determinants of drugs abuse such as i) formulation (dosage, extended or immediate
      release, route of administration) ii) geographical level iii) time factor (trends analysis
      between 2010 and 2015).

      Prescription drug abuse is a major challenge in public health, in particular in countries
      such as France, one of the main consumers of psychoactive medications in Europe. A single
      source of information is rarely sufficient to measure such a complex phenomenon. This project
      entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may
      complete efficiently the available data from the addictovigilance centres allowing the health
      authorities (French Drug Agency) to answer to the main general questions (What are the main
      prescription drug abused in France? What are the national trends in prescription drug abuse?
      What is the impact of a public health measures on prescription drug abuse).
observational model: Cohort
time perspective: Prospective
measure: psychoactive drug misuse
time frame: 2 years
description: the doctor shopping method,to assess medication availability and the extent and risk of abuse of all psychoactive reimbursed drugs at a national level according to the doctor shopping method.
All psychoactive drugs will be ranked according to their DSQ (used as a proxy of the extent of abuse) and their DSI (used as a proxy of abuse potential
intervention type: Other
intervention name: Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior
description: development and identification of systems and tools able to detect earlier misuse phenomenon
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urielle Desalbres
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Joelle MICALLEF
phone: 04 91 38 75 63
email: joelle.micallef@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor