The Effect of Valproate on Benzodiazepine Withdrawal Severity
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|ClinicalTrials.gov Identifier: NCT00570219|
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : October 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Substance Withdrawal Syndrome||Drug: valproate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
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
- benzodiazepine withdrawal severity [ Time Frame: 3 weeks ]
- benzodiazepine use [ Time Frame: 4 weeks after treatment ]
- attrition from treatment [ Time Frame: 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|