The Effect of Valproate on Benzodiazepine Withdrawal Severity

Substance Withdrawal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570219
• Other study ID #: PS05BENVAL
• Secondary ID: KLnro47/2005
• Status: Completed
• Phase: N/A
• First received: December 7, 2007
• Last updated: October 16, 2008
• Start date: February 2005
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of benzodiazepine dependence (DSM IV-R)

• Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance

Exclusion Criteria:

• Pregnancy

• History of convulsions

• Unstable somatic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	benzodiazepine withdrawal severity		3 weeks	No
Secondary	benzodiazepine use		4 weeks after treatment	No
Secondary	attrition from treatment		3 weeks	No