Primary Dependence to Analgesic Drugs

NCT03684317 | Unknown

• 1 other identifier: RC31/16/8914
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction

Keywords

Pharmacology; Psychiatry

Outcome Measures

Primary Outcomes (1)

• occurrence of complications in relation with primary drug dependence

  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

Secondary Outcomes (8)

• Incidence of analgesic drug dependence

  12 months

• Drug consumption in patients with primary dependence to analgesics

  12 months

• Drug consumption in patients with primary dependence to analgesics

  12 months

• Drug consumption in patients with primary dependence to analgesics

  12 months

• Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Maryse Lapeyre-Mestre, MD PhD

  University Hosptial Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryse Lapeyre-Mestre, MD

CONTACT

33-561145606; maryse.lapeyre-mestre@univ-tlse3.fr;

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: September 25, 2018
• Study Start: June 1, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

FR (1)