Primary Dependence to Analgesic Drugs

Addiction Clinical Trial

— NEO-ADDICT  

Official title:

Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03684317
• Other study ID #: RC31/16/8914
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: April 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: Maryse Lapeyre-Mestre, MD
• Phone: 33-561145606
• Email: maryse.lapeyre-mestre[@]univ-tlse3.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Locations

Country	Name	City	State
France	University Hospital toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of analgesic drug dependence	To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database	12 months
Secondary	Drug consumption in patients with primary dependence to analgesics	Change in duration of treatment between baseline and M12	12 months
Secondary	Drug consumption in patients with primary dependence to analgesics	Change in dose between baseline and M12	12 months
Secondary	Drug consumption in patients with primary dependence to analgesics	Change in number of drugs between baseline and M12	12 months
Secondary	Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences	Drug misuse (dose and/or duration superior to recommendations)	12 months
Secondary	Dependance	Doctor shopping behaviour (multiple different prescribers for the same drugs)	up to 12 months
Secondary	Initiation of a drug for opioid dependence		up to 12 months
Secondary	Mortality	Number of deaths between baseline and M12	up to 12 months