Alcohol Withdrawal Syndrome, Alcohol Dependence
Conditions
Keywords
alcohol withdrawal syndrome, treatment, sodium oxybate, oxazepam
Brief summary
Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms (AWS).
Detailed description
This is a phase IV, multicenter randomized (1:1), active drug-controlled study (double-blind, double dummy) with parallel groups evaluating the efficacy of SMO versus oxazepam in the treatment of AWS in alcohol-dependent patients. A placebo-controlled design was considered but excluded, given that a gold standard treatment for AWS is available (i.e., BDZs). Furthermore, considering that SMO and oxazepam have two different pharmaceutical formulation (suspension and tablets, respectively), a double-dummy design was adopted. Thus, all subjects will receive both medications, tablets (oxazepam or placebo) and suspension (SMO or placebo), at the same time.
Interventions
DRUGSodium Oxybate (SMO)
DRUGOxazepam
Sponsors
CT Pharmaceutical Industries, Sanremo - Italy
University of Bologna
Medical University of Vienna
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age range 21-75, * diagnosis of alcohol dependence according to DSM-IV criteria * the presence of AWS as assessed by Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale, a scoring system for quantitative evaluation of physical symptoms of AWS.20 Only subjects with a CIWA-Ar score equal to or higher than 10 (defined as moderate or severe AWS requiring pharmacological treatment) were ultimately enrolled in the study.
Exclusion criteria
* ≤55 kg of body weight; * history of withdrawal fits within 24 hours pre-study; * history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment; * dependence from narcotics, BDZs or other drugs of abuse; * documented pre-existent hypersensitivity to SMO or to BDZs, * renal failure (blood creatinine \>2•5 mg/dl and/or documented proteinuria \>500 mg/die), * heart failure, * severe respiratory failure * hepatic encephalopathy stage II-IV; * psychiatric disorders requiring treatment with psychoactive medications before the start of the study; * treatment with clonidine, haloperidol, bromocriptine during the last 3 months prior to participation in the study; * participation to other clinical investigations in the previous month prior to recruitment; * females whose could not assure not to become pregnant during the 1 month period of treatment, and during the subsequent 3 weeks; * subjects without a stable social condition or homeless.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of GHB compared to oxazepam on alcohol withdrawal symptoms | day 1, day 10, day 20 | The primary outcome was the reduction of symptoms of AWS reflected by the course of the total CIWA-Ar scores from the start (baseline) to the end of the study (day 10) and to the end of follow up (day 20, 10 days after drugs discontinuation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Course of alcohol abstinence | day 1, day 10, day 20 | Secondary outcome variables included the course of alcohol abstinence. In order to confirm daily alcohol abstinence, a breath analyzer was used. In addition, to define those subjects remaining abstinent throughout the whole treatment period, carbohydrate-deficient transferrin (%CDT) was evaluated at the time of screening and at the end of the treatment period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Craving for study drug. | day 1, day 10, day 20 | Assessment of craving for the study drug. |
Countries
Austria, Italy
Outcome results
None listed