Baclofen to help people taper off benzodiazepines for dependence
Official title: Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Run by Hospices Civils de Lyon · NCT05935553 · Data updated 2026-11-12
This trial will test whether taking baclofen (30 mg or 60 mg) helps adults with benzodiazepine dependence taper off their benzodiazepine medications compared with placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | October 30, 2028 |
| Study ends | October 30, 2028 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT05935553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with DSM-5 benzodiazepine use disorder who have used benzodiazepines for over 12 weeks, take 30–200 mg diazepam-equivalent daily, and have at least one prior treatment failure are the intended participants.
✕Probably not a fit
People outside the 18–65 age range, those using less than 30 mg or more than 200 mg diazepam-equivalent daily, or those without prior treatment failure may not be eligible or likely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled Phase 2/3 trial will assign adults with benzodiazepine use disorder to one of three groups: baclofen 30 mg, baclofen 60 mg, or placebo. Eligible participants are 18–65 years old, have used benzodiazepines continuously for more than 12 weeks, take between 30 and 200 mg diazepam-equivalent per day, and have at least one prior treatment failure. The investigational medication is given while participants follow a benzodiazepine taper protocol, with outcomes focused on reduction or discontinuation of benzodiazepine use. The study is led by Hospices Civils de Lyon and conducted at hospital sites in the Lyon area.
Why it matters
Potential benefit: If successful, baclofen could provide the first approved medication to help people reduce or stop long-term benzodiazepine use.
How similar studies have gone: There are case reports and uncontrolled clinical observations suggesting baclofen can help reduce benzodiazepine use, but randomized comparative evidence is limited and the approach remains largely unproven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Edouard Herriot
Lyon, France Recruiting -
Centre Hospitalier le Vinatier
Bron, France Not yet recruiting
Study contacts
- Study coordinator: Benjamin ROLLAND, PU, PH
- Email: Benjamin.rolland@chu-lyon.fr
- Phone: 04 37 91 50 72
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.