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Completed

NCT Number: NCT00570219

The Effect of Valproate on Benzodiazepine Withdrawal Severity

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.

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Key information

Conditions

Substance Withdrawal Syndrome Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Helsinki, Uusimaa, 09, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproate

Drug

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.

Other names: Deprakine depot

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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 10, 2007
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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