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MisuseMEGADOSENCT03254238

Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior

An observational study of Misuse, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Misuse
What is being tested?
Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior
How many people
10,000,000 participants
Where
1 siteFrance
Study dates
20 Dec 2017to 20 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The target population is the whole French population. The SNIIR-AM will be used as the source population. The SNIIR-AM (Systeme National d'Information Inter-Régime de l'Assurance Maladie) is the information system of the French National Health Insurance Scheme, containing individualized, anonymous, and exhaustive data on all health spending reimbursements of the overall French insured population (almost 65 million inhabitants). The information contained in this database covers the health care services reimbursed including: * Characteristics of medication dispensed (name, formulation, dates of prescription, date of dispensing, quantity dispensed and cost) * Patients characteristics including age, gender, area of residence, type of affiliation, dependency on the universal health care coverage or CMU (Couverture Médicale Universelle Complémentaire, CMUC, which is attributed to the unemployed and low income insurees, and which can be used as a proxy of the income level),

Who may be able to join

  • patients registered in the SNIIR-AM with at least one reimbursement of psychoactive drugs during the study period.

Who cannot join

  • French population not benefiting from social security

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

    Joelle MICALLEF, 04 91 38 75 63, joelle.micallef@ap-hm.fr

    Recruiting

Other trials in France

About this study

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

Read the detailed description

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).

Conditions
Misuse
Being tested
Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhaviorOther

    development and identification of systems and tools able to detect earlier misuse phenomenon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. psychoactive drug misuse

    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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study start20 Dec 2017
  3. Primary completion20 May 2018
  4. Study completion20 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254238
Sponsor's protocol ID
2016-50
Acronym
MEGADOSE
Status last verified
Jul 2020
First submitted
16 Aug 2017
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Misuse, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joelle MICALLEF (04 91 38 75 63, joelle.micallef@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

psychoactive drug misuse (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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