Actively Recruiting
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Led by Hospices Civils de Lyon · Updated on 2026-05-11
93
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Benzodiazepine dependence is a common condition with widespread use of benzodiazepines, which can lead to chronic addiction and complications. This research aims to evaluate how baclofen, a drug acting on related brain receptors, compares to placebo in helping reduce benzodiazepine doses in people with benzodiazepine use disorder. Baclofen's potential to aid benzodiazepine withdrawal has been observed but needs confirmation through this study. Participants will be randomly assigned to one of three groups: baclofen 30 mg daily, baclofen 60 mg daily, or placebo. The treatment lasts 13 weeks, including one week of dose increase, 11 weeks at full dose, and one week of dose reduction. All treatments are taken orally as capsules. During the study, participants will have their benzodiazepine consumption measured before and after the treatment period. Researchers will monitor safety, adverse events, withdrawal symptoms, craving, anxiety, depression, sleep quality, and quality of life through questionnaires and urine tests. The study duration averages about four and a half months, with regular assessments to track progress and effects.
CONDITIONS
Brief Title
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years
- Women of childbearing potential must have a negative pregnancy test at inclusion
- Women must use effective contraception during the trial and agree to pregnancy tests throughout
- Diagnosis of benzodiazepine use disorder (BUD) of any severity by DSM-5 criteria
- Average daily benzodiazepine dose between 30 mg and 200 mg diazepam equivalent over 28 days before inclusion
- Continued benzodiazepine use for more than 12 weeks
- At least one previous unsuccessful attempt to stop benzodiazepines
- Affiliated with a social security system
- Patients with or without guardianship
- Able to give free, informed, written consent
You will not qualify if you...
- Cirrhosis of the liver
- Significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, or renal failure
- Other health conditions deemed incompatible by the investigator
- Certain psychiatric disorders per DSM-5 and MINI 7.0.2 (schizophrenia, bipolar disorder, autism spectrum disorder)
- Suicidal state as identified by MINI 7.0.2
- Dependence on substances other than benzodiazepines and nicotine
- Previous use of baclofen for any indication
- Use of unauthorized combination therapies (including pregabalin, topiramate, ketamine, gabapentin, valproic acid, neuroleptics, and others)
- Pregnant or nursing women
- Hypersensitivity to baclofen or microcrystalline cellulose
- Participants under guardianship
- Patients who need to drive or operate machines during the 1-week dose escalation phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 13 weeks
Participants receive oral baclofen or placebo with dose escalation during the first week, maintenance at full dose for 11 weeks, and dose de-escalation during the last week.
Visits occur throughout the 13-week treatment period, including up to 6 visits assessing withdrawal symptoms, craving, anxiety, depression, sleep quality, and quality of life.
Trial Site Locations
Total: 2 locations
1
Centre Hospitalier le Vinatier
Bron, France, 69500
Not Yet Recruiting
2
Hôpital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
Research Team
B
Benjamin ROLLAND, PU, PH
S
Sonia Galletti
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here