Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

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).

NCT Number	NCT05935553
Lead Sponsor	Hospices Civils de Lyon
Conditions	Benzodiazepine Dependence
Enrollment	93 participants
Start Date	2026-01-15
Primary Completion	2028-10-30 (estimated)
Study Completion	2028-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-11