Clinical trial NCT03684317: Primary Dependence to Analgesic Drugs
Official title: Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Addiction
Keywords: Pharmacology
Psychiatry
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)

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

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

Primary outcomes:
measure: occurrence of complications in relation with primary drug dependence
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of analgesic drug dependence
timeFrame: 12 months
measure: Drug consumption in patients with primary dependence to analgesics
timeFrame: 12 months
measure: Drug consumption in patients with primary dependence to analgesics
timeFrame: 12 months
measure: Drug consumption in patients with primary dependence to analgesics
timeFrame: 12 months
measure: Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences
timeFrame: 12 months
measure: Dependance
timeFrame: up to 12 months
measure: Initiation of a drug for opioid dependence
timeFrame: up to 12 months
measure: Mortality
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital toulouse
Study officials:
affiliation: University Hosptial Toulouse
name: Maryse Lapeyre-Mestre, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: