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Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

NCT05935553•Hospices Civils de Lyon

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 50 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.
+2 more criteria

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.
+2 more criteria

Locations (2)

Centre Hospitalier le Vinatier

Bron, France

Hôpital Edouard Herriot

Lyon, France

Key Dates

Start Date

January 15, 2026

Primary Completion Date

October 30, 2028

Completion Date

October 30, 2028

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Benzodiazepine Dependence

Interventions

Baclofen 30 mg

DRUG

Baclofen 60 mg

DRUG

Placebo

DRUG

Contacts

Benjamin ROLLAND, PU, PH

CONTACT

04 37 91 50 72 Benjamin.rolland@chu-lyon.fr

Sonia Galletti

CONTACT

04 27 85 77 39 Sonia.galletti@chu-lyon.fr

Blended Care for the Discontinuation of Benzodiazepine Use

NCT03937180

Benzodiazepine DependenceBenzodiazepine Dependent+1 more

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TERMINATEDPHASE2

Gabapentin Treatment of Benzodiazepine Dependence

NCT01893632

Benzodiazepine Dependence

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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