NCT05935553 Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
| NCT ID | NCT05935553 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hospices Civils de Lyon |
| Condition | Benzodiazepine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 93 participants in total. It began in 2026-01-15 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Patients aged ≥ 18 years to ≤ 65 years * For women of childbearing potential : * 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. * BUD of any severity defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria * Average daily benzodiazepine dosage between 30 mg and 200 mg-diazepam (according to Ashton equivalence table) over the 28 days prior to inclusion. Benzodiazepine equivalents (zolpidem, zopiclone and eszopiclone) will be counted as part of the total equivalent daily dose of diazepam and will also be included in the tapering procedure. * Continued use of benzodiazepines for more than 12 weeks * At least one history of BUD treatment failure. A treatment failure is defined as a failure to withdraw from the full dose (i.e., discontinuation of benzodiazepine and related prescriptions) according to a previously established tapering schedule, by a general practitioner or specialist * Patient affiliated to a social security system. * Patients with or without guardianship * Patient capable of giving free, informed and written consent. Exclusion Criteria: * 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) * Suicidal state identified using MINI 7.0.2 * Dependence on substances or drugs other than benzodiazepines and nicotine (dependence will be identified through the use of MINI 7.0.2) * History of baclofen use for all indications * Unauthorized combination therapies will be: pregabalin, topiramate, ketamine, sodium oxybate, gabapentin, valproic acid, sodium valproate, melatonin, buspirone, hydroxyzine, propranolol, bisoprolol, etifoxin, carbamazepine, clonidine, paroxetine, all neuroleptic/antipsychotic class therapies, and tricyclic antidepressants * Pregnant or nursing women * Hypersensitivity to baclofen or microcrystalline cellulose. * Participants under guardianship * Patients who need to drive and/or use machines during the 1-week dose escalation phase
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05935553 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Benzodiazepine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05935553 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05935553 currently recruiting?
Yes, NCT05935553 is actively recruiting participants. Contact the research team at Benjamin.rolland@chu-lyon.fr for enrollment information.
Where is the NCT05935553 trial being conducted?
This trial is being conducted at Bron, France, Lyon, France.
Who is sponsoring the NCT05935553 clinical trial?
NCT05935553 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 93 participants.