Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence. Babet

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Trial duration

15 Jan 2026 → ongoing

Decision date (initial)

2024-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Institut pour la Recherche en Santé Publique

External identifiers

EU CT number

2022-502307-30-00

ClinicalTrials.gov

NCT05935553

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder

Secondary objectives 3

1. To assess the safety of baclofen in reducing benzodiazepine doses in patients with benzodiazepine use disorder
2. To assess the efficacy of baclofen on increasing the frequency of discontinuation of benzodiazepine use after 4 months
3. To assess the efficacy of baclofen on quality of sleep, symptoms of anxiety, symptoms of depression, quality of life, craving and withdrawal symptoms.

Conditions and MedDRA coding

Psychiatrics disorders, addictology

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients aged ≥ 18 years to ≤ 65 years
2. 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.
3. benzodiazepine use disorder (BUD) of any severity defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
4. Average daily benzodiazepine dosage between 30 mg and 200mg-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
5. Continued use of benzodiazepines for more than 12 weeks
6. 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
7. Patient affiliated to a social security system
8. Patient capable of giving free, informed and written consent
9. Patient with or without guardianship

Exclusion criteria 14

1. Cirrhosis of the liver
2. Non-compatible health conditions (at the discretion of the investigator)
3. 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)
4. Suicidal state assessed by the RUD (Risk Danger Urgency) test
5. Dependence on substances or drugs other than benzodiazepines and nicotine
6. History of baclofen use for all indications
7. 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
8. Pregnant or nursing women
9. Hypersensitivity to baclofen or microcrystalline cellulose
10. Participants under guardianship
11. Patients who need to drive and/or use machines during the 1-week dose escalation phase
12. Patients with significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, renal failure, etc.
13. Patients with a history of cerebrovascular disease, gastric or duodenal ulcers and Parkinson's disease
14. Patients with porphyria

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in total benzodiazepine consumption, in mg-diazepam, between the 28 days before inclusion in the clinical trial and the last 28 days the last 28 days before visit 5 on Day 62/64 of randomisation

Secondary endpoints 3

1. Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations.
2. Frequency of benzodiazepine discontinuation at the last visit of the treatment period (self-report and urine test); Benzodiazepine withdrawal severity score assessed by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B)
3. Craving score assessed by the Visual Analog Scale (VAS), Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y), Depression score assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), Quality of life (SF-12 v2).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Benjamin ROLLAND

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Benjamin ROLLAND

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications