NCT00570219

The Effect of Valproate on Benzodiazepine Withdrawal Severity

The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Substance Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	valproate	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.

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-12-10
• Last updated: 2008-10-17

Locations

1 site across 1 country: Finland