- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03684317
Primary Dependence to Analgesic Drugs (NEO-ADDICT)
18. august 2022 opdateret af: University Hospital, Toulouse
Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting
Abuse of analgesics represents an important part of prescription drug abuse.
The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context.
This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin).
In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal.
Trends of growing abuse are also reported for other analgesics.
Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse.
There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care.
Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected.
Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
To date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored.
By reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications.
Pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence.
By definition, specialized care seeking can only be achieved after emergence and identification of the problem.
Outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption
Undersøgelsestype
Observationel
Tilmelding (Forventet)
10000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maryse Lapeyre-Mestre, MD
- Telefonnummer: 33-561145606
- E-mail: maryse.lapeyre-mestre@univ-tlse3.fr;
Studiesteder
-
-
-
Toulouse, Frankrig
- Rekruttering
- University Hospital Toulouse
-
Kontakt:
- Maryse Lapeyre-Mestre, MD PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)
Beskrivelse
Inclusion Criteria:
- Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
- Age >18 at index date (date of first analgesic dispensing)
- At least three dispensing of analgesic drugs
- At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
- No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)
Exclusion Criteria:
- none
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
occurrence of complications in relation with primary drug dependence
Tidsramme: 12 months
|
occurrence of complications in relation with primary drug dependence (hospitalization for complications related to analgesic use, long term condition or initiation of drug for opioid dependence)
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of analgesic drug dependence
Tidsramme: 12 months
|
To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Tidsramme: 12 months
|
Change in duration of treatment between baseline and M12
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Tidsramme: 12 months
|
Change in dose between baseline and M12
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Tidsramme: 12 months
|
Change in number of drugs between baseline and M12
|
12 months
|
Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences
Tidsramme: 12 months
|
Drug misuse (dose and/or duration superior to recommendations)
|
12 months
|
Dependance
Tidsramme: up to 12 months
|
Doctor shopping behaviour (multiple different prescribers for the same drugs)
|
up to 12 months
|
Initiation of a drug for opioid dependence
Tidsramme: up to 12 months
|
up to 12 months
|
|
Mortality
Tidsramme: up to 12 months
|
Number of deaths between baseline and M12
|
up to 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Maryse Lapeyre-Mestre, MD PhD, University Hosptial toulouse
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2019
Primær færdiggørelse (Forventet)
1. april 2023
Studieafslutning (Forventet)
1. april 2023
Datoer for studieregistrering
Først indsendt
18. juli 2018
Først indsendt, der opfyldte QC-kriterier
24. september 2018
Først opslået (Faktiske)
25. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC31/16/8914
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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