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CompletedNCT00570219Updated Oct 17, 2008

The Effect of Valproate on Benzodiazepine Withdrawal Severity

An interventional study of valproate in Substance Withdrawal Syndrome, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-17.

Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Substance Withdrawal Syndrome
03

In context

Substance Withdrawal Syndrome

128 studies on the registry are indexed under Substance Withdrawal Syndrome; 8 are open to participants now.

This study's enrollment of 30 is below the median of 53 across 93 interventional studies indexed under Substance Withdrawal Syndrome.

Browse Substance Withdrawal Syndrome studies →

Lead sponsor

University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy
  • History of convulsions
  • Unstable somatic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    B

    Gradual benzodiazepine discontinuation and valproate treatment

    Drug: valproate

  • No intervention
    A

    Gradual benzodiazepine discontinuation

Interventions

  • Drugvalproate

    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.

    Also known as: Deprakine depot

06

What researchers measure

Primary outcomes

  1. benzodiazepine withdrawal severity

    Time frame: 3 weeks

Secondary outcomes

  1. benzodiazepine use

    Time frame: 4 weeks after treatment

  2. attrition from treatment

    Time frame: 3 weeks

07

Study locations

1 site
  • Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence
    Helsinki, Uusimaa 09, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00570219
Lead sponsor
University of Helsinki
First posted
Dec 10, 2007
Start date
Feb 2005
Primary completion
May 2008
Completion
May 2008
Last update
Oct 17, 2008

Study contacts

Helena Vorma, MD, Ph.D
principal investigator · Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry
Katila Heikki, Md, Ph.D
study director · Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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