NEO-ADDICT: Primary Dependence to Analgesic Drugs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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
Study Design
Outcome Measures
Primary Outcome Measures
- occurrence of complications in relation with primary drug dependence [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)
Secondary Outcome Measures
- Incidence of analgesic drug dependence [12 months]
To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database
- Drug consumption in patients with primary dependence to analgesics [12 months]
Change in duration of treatment between baseline and M12
- Drug consumption in patients with primary dependence to analgesics [12 months]
Change in dose between baseline and M12
- Drug consumption in patients with primary dependence to analgesics [12 months]
Change in number of drugs between baseline and M12
- Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences [12 months]
Drug misuse (dose and/or duration superior to recommendations)
- Dependance [up to 12 months]
Doctor shopping behaviour (multiple different prescribers for the same drugs)
- Initiation of a drug for opioid dependence [up to 12 months]
- Mortality [up to 12 months]
Number of deaths between baseline and M12
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
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Age >18 at index date (date of first analgesic dispensing)
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At least three dispensing of analgesic drugs
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At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
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No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital toulouse | Toulouse | France |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Maryse Lapeyre-Mestre, MD PhD, University Hosptial Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/16/8914