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Clinical Trial Summary

Benzodiazepines and related molecules are among the most prescribed psychotropic treatments in France and Europe. 13.4% of the French population had at least one reimbursement of benzodiazepines in 2015, which places France second in Europe. However, the chronic use of benzodiazepines is a source of numerous complications, particularly addictive. To date, there is no authorized pharmacological treatment for benzodiazepine withdrawal. Baclofen is a gamma-aminobutyric acid (GABA)-B agonist, a pharmacological receptor that regulates GABA-A, the target of benzodiazepines. The pharmacological mechanisms of baclofen are therefore related to those of benzodiazepines. Empirical use outside of the MA has shown that baclofen can facilitate the reduction of benzodiazepines in cases of severe addiction, but this pharmaceutical interest remains to be demonstrated in a comparative study. The main objective of the project is to evaluate the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder (BUD).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05935553
Study type Interventional
Source Hospices Civils de Lyon
Contact Benjamin ROLLAND, PU, PH
Phone 04 37 91 50 72
Email Benjamin.rolland@chu-lyon.fr
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date March 1, 2024
Completion date December 1, 2026

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