Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
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).