Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
ConditionBenzodiazepine Dependence
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospices Civils de Lyon
About this trial
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).
Eligibility criteria
Qualifiers
Patients aged ≥ 18 years to ≤ 65 years
negative pregnancy test at inclusion
and use of effective contraception which will be continued throughout the trial period
and agrees to carry out pregnancy tests throughout the trial period.
Disqualifiers
Cirrhosis of the liver
Patients with significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, renal failure, etc.
Non-compatible health conditions (at the discretion of the investigator)
The following psychiatric conditions as defined by DSM-5 criteria: schizophrenic disorder, persistent delusional disorder, schizophreniform disorder, schizoaffective disorder, bipolar disorder, autism spectrum disorder identified using the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2)
Trial design
Treatments tested in this trial
- Baclofen 30 mg
- Baclofen 60 mg
- Placebo
Treatment groups
93 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov