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Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

Study acronym: BABET
StatusRecruiting
PhasePhase 2/3
Started2026-01-15
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Study Status, Eligibility v4
Eligibility criteriarevised
[...] DSM) 5 criteria Average daily benzodiazepine dosage between 5030 mg and 200 mg-diazepam (according to Ashton equivalence tab [...]
2026-01-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-09-01→2028-10-30
Completion date2027-09-01→2028-10-30
Start dateestimated 2024-12-01→confirmed 2026-01-15
Study sitesdetails revised at 2 of 2 sites
2024-09-06
Study Identification, Study Status v2
Primary completion date2026-12-01→2027-09-01
Completion date2026-12-01→2027-09-01
Start date2024-03-01→2024-12-01
2023-10-27
Study Status, Eligibility v1
Primary completion date2026-08-15→2026-12-01
Completion date2026-12-15→2026-12-01
Start date2023-11-01→2024-03-01
Eligibility criteria+112 characters
Inclusion Criteria: Patients aged ≥ 18 years to ≤ 65 years For women of childbearing potential : negative pregnancy test at inclusion and use of effective contraceptivescontraception which will be continued throughout the trial period and agrees to carry out pregnancy tests throughout the trial period. BUD of any severity defined according to Diagnostic and Stat [...] orders (DSM) 5 criteria Average daily benzodiazepine dosage ≥between 50 mg and 200 mg-diazepam (according to Ashton equivalence table) over th [...] ays prior to inclusion. Benzodiazepine equivalents (zolpidem, zopiclone and zopicloneeszopiclo [...] [...]
2023-06-29
Original filing
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).
Trial Details
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