The Effect of Valproate on Benzodiazepine Withdrawal Severity

University of Helsinki

Status: Completed

Conditions: Substance Withdrawal Syndrome

Treatments: Drug: valproate

Study type: Interventional

Funder types: Other

Identifiers

NCT00570219

KLnro47/2005

PS05BENVAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

B

Experimental group

Description:

Gradual benzodiazepine discontinuation and valproate treatment

Treatment:

Drug: valproate

A

No Intervention group

Description:

Gradual benzodiazepine discontinuation