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Study identifier: NCT05935553 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

Condition: Benzodiazepine Dependence  ·  Sponsor: Hospices Civils de Lyon

PhasePhase 2/Phase 3
Planned participants93
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Benjamin ROLLAND, PU, PH  ·  04 37 91 50 72  ·  Benjamin.rolland@chu-lyon.fr

Sonia Galletti  ·  04 27 85 77 39  ·  Sonia.galletti@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (2)

Centre Hospitalier le VinatierBron, FranceNot Yet Recruiting
Hôpital Edouard HerriotLyon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05935553