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The Effect of Valproate on Benzodiazepine Withdrawal Severity

Not Applicable
Completed
Conditions
Substance Withdrawal Syndrome
Interventions
Registration Number
NCT00570219
Lead Sponsor
University of Helsinki
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BvalproateGradual benzodiazepine discontinuation and valproate treatment
Primary Outcome Measures
NameTimeMethod
benzodiazepine withdrawal severity3 weeks
Secondary Outcome Measures
NameTimeMethod
attrition from treatment3 weeks
benzodiazepine use4 weeks after treatment

Trial Locations

Locations (1)

Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence

🇫🇮

Helsinki, Uusimaa, Finland

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