The Effect of Valproate on Benzodiazepine Withdrawal Severity
The aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients|
- benzodiazepine withdrawal severity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- benzodiazepine use [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
- attrition from treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Gradual benzodiazepine discontinuation and valproate treatment
Valproate 20 mg/kg per day for 2 weeks, reduction during week 3. Conversion of benzodiazepines to an equivalent dose of diazepam (maximum 80 mg per day). Dosage reduced 10 mg daily until 40 mg per day. Reduction then continued 5 mg daily.
Other Name: Deprakine depot
No Intervention: A
Gradual benzodiazepine discontinuation
In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths.
Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570219
|Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence|
|Helsinki, Uusimaa, Finland, 09|
|Principal Investigator:||Helena Vorma, MD, Ph.D||Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry|
|Study Director:||Katila Heikki, Md, Ph.D||Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry|