Study identification

PURI

https://redirect.ema.europa.eu/resource/28047

EU PAS number

EUPAS10298

Study ID

28047

Official title and acronym

Pregabalin abuse in France : a national cohort study

DARWIN EU® study

No

Study countries

France

Study description

Pregabalin is a psychoactive drug indicated in neuropathic pain, generalized anxiety disorder and partial epilepsy. It modifies neuronal activity, binding α2δ1 presynaptic voltage-dependent calcic channel receptor, which is responsible for its psychotropic action. Neuropsychiatric adverse drug reactions, such as euphoria, have been described. Pregabalin abuse has been suggested in a few toxicological studies, pharmacovigilance studies, and small surveys among opioid users or treated by opiate maintenance drugs. Despite signals of abuse in some European countries, no data suggest a potential for pregabalin abuse in France, and no study has ever compare pregabalin abuse to other drug used in the same indication. Searching a possible pregabalin abuse seems all the more relevant as its consumption increases in France and in Europe. This study aims to investigate pregabalin abuse and its frequency in the French general population, in comparison with other drugs used in similar indications and to determine the factors associated with pregabalin abuse.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Maryse Lapeyre-Mestre

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Toulouse University Hospital
Study protocol
Initial protocol

Pregabalin study protocol 15_07

English (666.05 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable