Benzodiazepine DependencePhase 2/3BABETNCT05935553
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
A Phase 2/3 study testing Baclofen 30 mg and Baclofen 60 mg in people with Benzodiazepine Dependence, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benzodiazepine Dependence
- What is being tested?
- Baclofen 30 mg and Baclofen 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2026to 30 Oct 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier le Vinatier
Bron, 69500
Christophe ICARD, MD, PhD, 04 37 91 50 75 ext. +33, christophe.icard@ch-le-vinatier.fr
Christophe ICARD, MD, PhD
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Benjamin ROLLAND, PU, PH, 04 37 91 50 72 ext. +33, Benjamin.rolland@chu-lyon.fr
Sonia Galletti, 04 27 85 77 39 ext. +33, Sonia.galletti@chu-lyon.fr
About this study
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.
Read more
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).
- Conditions
- Benzodiazepine Dependence
- Being tested
- Baclofen 30 mg, Baclofen 60 mg, Placebo
- Keywords
- Benzodiazepine Dependence, baclofen, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 30 mgDrug
- baclofen 10 mg capsule (for the 30 mg-baclofen 30 mg arm)
- Dosage: 3 capsules of baclofen 10 mg per day
- route of administration: Oral
- duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
Baclofen 60 mgDrug
- baclofen 20 mg capsule (for the 60 mg baclofen arm)
- Dosage: 3 capsules of baclofen 20 mg per day
- route of administration: Oral
- duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
PlaceboDrug
- placebo capsule (for the placebo arm)
- Dosage:3 capsules of placebo per day
- route of administration: Oral
- duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
| Study group | Role | What they receive |
|---|---|---|
| Baclofen 30 microgram (mg) treatment | Experimental | baclofen treatment (30 mg/per day) Receives: Drug: Baclofen 30 mg |
| Baclofen 60 mg | Experimental | baclofen treatment (60 mg/per day) Receives: Drug: Baclofen 60 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total benzodiazepine consumption, in mg-diazepam
This difference will be compared between the two groups (winning baclofen group and placebo group). Total benzodiazepine consumption will be measured using the Benzodiazepine Timeline Follow-Back (B-TLFB). A mean value (in mg/d) for the 28 days of consumption will be calculated for each patient (between the 28 days prior to inclusion in the clinical trial and the last 28 days of the clinical trial).
Measured: between the 28 days before inclusion in the clinical trial and the last 28 days of the clinical trial
Secondary outcomes (11)
Frequency of serious adverse events of special interest
The frequency of serious adverse events of particular interest will be collected from inclusion to the end of the study for each patient.
Measured: through study completion, an average of 4 and a half months
Frequency of non-serious adverse events of special interest
The frequency of non-serious adverse events of particular interest will be collected from inclusion to the end of the study for each patient.
Measured: through study completion, an average of 4 and a half months
frequency of all-cause study discontinuations
frequency of all-cause study discontinuations will be collected from inclusion to the end of the study for each patient.
Measured: through study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by urine test
Toxicology will be measured by a urine test during the last visit of the treatment period.
Measured: at study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by B-TLFB questionnaire
Frequency of benzodiazepine discontinuation at the last visit of the treatment period will collected by B-TLFB questionnaire.
The B-TLFB involves asking patients to retrospectively estimate their benzodiazepine consumption.
Measured: at study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B) questionnaire
The severity score for benzodiazepine withdrawal will be assessed at visit 1 to visit 6 by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B).The B-TLFB involves asking patients to retrospectively estimate their benzodiazepine consumption.
The CIWA-B comprises client-reported symptoms and clinical observations. Questions 1-11 and 13-17 are client-reported symptoms, with each scored on five-point scales from 0 = not at all to 4 = very much so. Question 12 is also a client-reported item, but the 5 scale is reversed, i.e., 0 = Very much so to 4 = Not at all. Questions 18-20 are clinical observations, with all three scored on five-point scales (i.e. 0, 1, 2, 3 or 4).
A total score is obtained by summing questions 1-20: The minimum total score possible is 0, and the maximum total score possible is 80.
1-20 Mild withdrawal 21-40 Moderate withdrawal 41-60 Severe withdrawal 61-80 Very severe withdrawal
Measured: up to visit 6, an average of 3 and a half months
Craving score assessed by the Visual Analog Scale (VAS)
Craving score assessed by the Visual Analog Scale (VAS) will be collected at visit 1 to visit 6.
Measured: up to visit 6, an average of 3 and a half months
Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y)
Anxiety symptoms will be evaluated by the State Trait Inventory Anxiety (STAI-Y) collected at visit 1 and visit 6. It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages.
Measured: up to visit 6, an average of 3 and a half months
Depression score assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Depression score will be evaluated by the MADRS questionnaire collected at visit 1 and visit 6.
It assesses the severity of symptoms in a wide range of areas, such as mood, sleep and appetite, physical and mental fatigue and thoughts of suicide.
The scale comprises 10 items rated from 0 to 6. 0 to 6 points: the patient is considered to be healthy. 7 to 19 points: the patient is considered to be mildly depressed. 20 to 34 points: the patient is considered to have moderate depression. > 34 points: the patient is considered to have severe depression.
Measured: up to visit 6, an average of 3 and a half months
Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Subjective sleep quality will be evaluated by the PSQI questionnaire collected at visit 1 to visit 6.* The PSQI consists of 19 self-assessment questions and 5 questions asked of the spouse or roommate (if any). Only the self-assessment questions are included in the score.
The 19 self-assessment questions combine to give 7 'components' of the overall score, with each component receiving a score from 0 to 3.
In all cases, a score of 0 indicates that there are no difficulties, while a score of 3 indicates the existence of severe difficulties. The 7 components of the score are added together to give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.
Measured: up to visit 6, an average of 3 and a half months
Quality of life (SF-12 v2)
The SF-12 questionnaire will be collected to visit 1 and visit 6. It is a 12-item short-form health survey that assesses the same eight health domains as the SF-36v2® Health Survey, acting as an abridged version with one or two questions per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Lower scores indicating better physical and mental health functioning
Measured: up to visit 6, an average of 3 and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start15 Jan 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benzodiazepine DependenceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935553
- Sponsor's protocol ID
- 69HCL21_1318
- Other IDs
- 2022-502307-30-00
- Acronym
- BABET
- Status last verified
- May 2026
- First submitted
- 29 Jun 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
- ClinicalTrials.gov ID
- NCT05935553
- Acronym / sponsor ID
- BABET / 69HCL21_1318
- Conditions
- Benzodiazepine Dependence
- Keywords
- Benzodiazepine Dependence, baclofen, efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baclofen 30 microgram (mg) treatment | Experimental | Drug: Baclofen 30 mgbaclofen treatment (30 mg/per day) |
| Baclofen 60 mg | Experimental | Drug: Baclofen 60 mgbaclofen treatment (60 mg/per day) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged ≥ 18 years to ≤ 65 years
- For women of childbearing potential :
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen 30 mg* baclofen 10 mg capsule (for the 30 mg-baclofen 30 mg arm) * Dosage: 3 capsules of baclofen 10 mg per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation | Drug | Baclofen 30 microgram (mg) treatment |
| Baclofen 60 mg* baclofen 20 mg capsule (for the 60 mg baclofen arm) * Dosage: 3 capsules of baclofen 20 mg per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation | Drug | Baclofen 60 mg |
| Placebo* placebo capsule (for the placebo arm) * Dosage:3 capsules of placebo per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation | Drug | Placebo |
Primary outcome
Difference in total benzodiazepine consumption, in mg-diazepam
Time frame: between the 28 days before inclusion in the clinical trial and the last 28 days of the clinical trial
This difference will be compared between the two groups (winning baclofen group and placebo group). Total benzodiazepine consumption will be measured using the Benzodiazepine Timeline Follow-Back (B-TLFB). A mean value (in mg/d) for the 28 days of consumption will be calculated for each patient (between the 28 days prior to inclusion in the clinical trial and the last 28 days of the clinical trial).
11 secondary outcomes
Frequency of serious adverse events of special interest
Time frame: through study completion, an average of 4 and a half months
Frequency of non-serious adverse events of special interest
Time frame: through study completion, an average of 4 and a half months
frequency of all-cause study discontinuations
Time frame: through study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by urine test
Time frame: at study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by B-TLFB questionnaire
Time frame: at study completion, an average of 4 and a half months
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B) questionnaire
Time frame: up to visit 6, an average of 3 and a half months
Craving score assessed by the Visual Analog Scale (VAS)
Time frame: up to visit 6, an average of 3 and a half months
Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y)
Time frame: up to visit 6, an average of 3 and a half months
Depression score assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: up to visit 6, an average of 3 and a half months
Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to visit 6, an average of 3 and a half months
Quality of life (SF-12 v2)
Time frame: up to visit 6, an average of 3 and a half months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baclofen 30 mg and Baclofen 60 mg in people with Benzodiazepine Dependence, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin ROLLAND, PU, PH (04 37 91 50 72 ext. +33, Benjamin.rolland@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in total benzodiazepine consumption, in mg-diazepam (time frame: between the 28 days before inclusion in the clinical trial and the last 28 days of the clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.