drugset / Trial / NCT00597701
Treating Alcohol Withdrawal With Oral Baclofen
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit \[ICU\] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.
Timeline
- Start
- 2003-04
- Primary completion
- 2008-02
- Completion
- 2008-02
Publications
- Background Colombo G, Agabio R, Carai MA, Lobina C, Pani M, Reali R, Addolorato G, Gessa GL. Ability of baclofen in reducing alcohol intake and withdrawal severity: I--Preclinical evidence. Alcohol Clin Exp Res. 2000 Jan;24(1):58-66.
- Background Addolorato G, Caputo F, Capristo E, Janiri L, Bernardi M, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002 Feb 15;112(3):226-9. doi: 10.1016/s0002-9343(01)01088-9. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Baclofen | Small molecule | 10 mg | Oral |
| Comparator | Lorazepam | Small molecule | — | — |