NCT05935553

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Benzodiazepine Dependence

Interventions

Type	Name	Description
DRUG	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 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	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

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2023-07-07
• Last updated: 2026-01-30

Locations

2 sites across 1 country: France