N/A
N=46
Treating Alcohol Withdrawal With Oral Baclofen
Alcohol Withdrawal Delirium
Bottom Line
View on ClinicalTrials.gov: NCT00597701 ↗Enrolled (actual)
46
Serious AEs
6.8%
Results posted
Jul 2011
Primary outcome: Primary: Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups — 14.1; 124.4 mg of benzodiazepine per 8 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Baclofen (Drug); Placebo (Drug); Lorazepam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Essentia Health
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups |
14.1; 124.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for alcohol withdrawal syndrome (AWS).
- Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment.
- Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy.
- Agree to abstain for alcohol for duration of study.
- Be able to provide informed consent.
Exclusion Criteria
- The patient must not have any other active drug dependence in addition to alcohol.
- Be unwilling or unable to forgo alcohol for the duration of the study.
- Be using baclofen at the time of study enrollment.
- Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment.
- have known baclofen or benzodiazepine sensitivity.
- Be unable to take oral (PO) meds.
- Be unable to complete one of two consenting procedures.
- Be pregnant or breastfeeding.
- Have a serum creatine level > 2.0.
- Have a history of non alcoholic withdrawal seizures.
Data sourced from ClinicalTrials.gov (NCT00597701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.