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The Effect of Valproate on Benzodiazepine Withdrawal Severity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570219
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : October 17, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Substance Withdrawal Syndrome Drug: valproate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients
Study Start Date : February 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: B
Gradual benzodiazepine discontinuation and valproate treatment
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.
Other Name: Deprakine depot

No Intervention: A
Gradual benzodiazepine discontinuation

Primary Outcome Measures :
  1. benzodiazepine withdrawal severity [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. benzodiazepine use [ Time Frame: 4 weeks after treatment ]
  2. attrition from treatment [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • Pregnancy
  • History of convulsions
  • Unstable somatic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570219

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Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence
Helsinki, Uusimaa, Finland, 09
Sponsors and Collaborators
University of Helsinki
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Principal Investigator: Helena Vorma, MD, Ph.D Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry
Study Director: Katila Heikki, Md, Ph.D Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry

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Responsible Party: Helena Vorma (principal investigator), Helsinki University Central Hospital, Department of Psychiatry Identifier: NCT00570219    
Other Study ID Numbers: PS05BENVAL
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs