Could a muscle relaxant help people quit anxiety meds?
NCT ID NCT05935553
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether baclofen, a muscle relaxant, can help people dependent on benzodiazepines (like Valium or Xanax) safely reduce their dose. About 93 adults with moderate to severe dependence will receive either baclofen or a placebo for several weeks. The goal is to see if baclofen makes tapering easier and safer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier le Vinatier
NOT_YET_RECRUITINGBron, 69500, France
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Hôpital Edouard Herriot
RECRUITINGLyon, 69003, France
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