drugset / Trial / NCT01604330
Baclofen for the Treatment of Alcohol Drinkers
Phase 2/3
Completed
323 enrolled
Assistance Publique - Hôpitaux de Paris
Hôpital Cochin · collabSociété de Formation Thérapeutique du Généraliste · collabURC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.
Timeline
- Start
- 2012-05-29
- Primary completion
- 2014-09
- Completion
- 2015-10
Outcome
Met primary endpoint
paper Primary success rates were 57 and 36% in the baclofen and placebo arms, respectively [difference: 21 percentage points, 95% confidence interval (CI) = 8-34 PMID 31833590 ↗
Publications
- Results Rigal L, Sidorkiewicz S, Treluyer JM, Perrodeau E, Le Jeunne C, Porcher R, Jaury P. Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up. Addiction. 2020 Jul;115(7):1265-1276. doi: 10.1111/add.14927. Epub 2020 Feb 16.
- Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baclofen | Small molecule | 300 mg | Oral |