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Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
ID05935553

Evaluating Baclofen Treatment to Reduce Benzodiazepine Use in Adults with Benzodiazepine Dependence

Led by Hospices Civils de Lyon · Updated on 2026-05-11

93

Participants Needed

2

Research Sites

N/A

Total Duration

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. Baclofens 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

Research Team

B

Benjamin ROLLAND, PU, PH

S

Sonia Galletti

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