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New treatment option for Benzodiazepine Dependence
Official title Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
ClinicalTrials.gov ID: NCT05935553
What this study is testing
What is Baclofen 30 mg?
Baclofen 30 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for benzodiazepine dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- 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...
- Patient affiliated to a social security system.
- Patients with or without guardianship
- Patient capable of giving free, informed and written consent.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Lyon, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.