Actively Recruiting
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Led by Hospices Civils de Lyon · Updated on 2026-05-11
93
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years to 65 years
- Women of childbearing potential must have a negative pregnancy test at inclusion
- Women of childbearing potential must use effective contraception throughout the trial and agree to pregnancy tests during the trial
- Diagnosis of benzodiazepine use disorder (BUD) of any severity by DSM-5 criteria
- Average daily benzodiazepine dose between 30 mg and 200 mg diazepam equivalent over the 28 days before inclusion
- Continued benzodiazepine use for more than 12 weeks
- At least one previous failure to withdraw from benzodiazepines according to a tapering schedule
- Affiliated to a social security system
- Patients with or without guardianship
- Capable of providing free, informed, and written consent
You will not qualify if you...
- Cirrhosis of the liver
- Significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, or renal failure
- Non-compatible health conditions at investigator's discretion
- Psychiatric disorders including schizophrenia, persistent delusional disorder, schizophreniform disorder, schizoaffective disorder, bipolar disorder, autism spectrum disorder
- Suicidal state
- Dependence on substances other than benzodiazepines and nicotine
- Prior use of baclofen for any reason
- Use of unauthorized combination therapies including pregabalin, topiramate, ketamine, sodium oxybate, gabapentin, valproic acid, melatonin, buspirone, hydroxyzine, propranolol, bisoprolol, etifoxin, carbamazepine, clonidine, paroxetine, neuroleptics/antipsychotics, and tricyclic antidepressants
- Pregnant or nursing women
- Hypersensitivity to baclofen or microcrystalline cellulose
- Participants under guardianship
- Patients who need to drive or use machines during the 1-week dose escalation phase
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre Hospitalier le Vinatier
Bron, France, 69500
Not Yet Recruiting
2
Hôpital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
Research Team
B
Benjamin ROLLAND, PU, PH
CONTACT
S
Sonia Galletti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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