Primary Dependence to Analgesic Drugs

NCT ID: NCT03684317

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2023-04-30

Brief Summary

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.

Detailed Description

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

Conditions

Addiction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryse Lapeyre-Mestre, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hosptial Toulouse

Locations

University Hospital toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maryse Lapeyre-Mestre, MD

Role: CONTACT

maryse.lapeyre-mestre@univ-tlse3.fr;

33-561145606

Facility Contacts

Maryse Lapeyre-Mestre, MD PhD

Role: primary

Other Identifiers

RC31/16/8914

Identifier Type: -

Identifier Source: org_study_id