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The Effect of Valproate on Benzodiazepine Withdrawal Severity

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00570219
First received: December 7, 2007
Last updated: October 16, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
Substance Withdrawal Syndrome
 Drug: valproate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • benzodiazepine withdrawal severity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • benzodiazepine use [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
  • attrition from treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570219

Locations
Finland
Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence
Helsinki, Uusimaa, Finland, 09
Sponsors and Collaborators
Helsinki University
Investigators
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
  More Information

No publications provided

Responsible Party: Helena Vorma (principal investigator), Helsinki University Central Hospital, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00570219     History of Changes
Other Study ID Numbers: PS05BENVAL, KLnro47/2005
Study First Received: December 7, 2007
Last Updated: October 16, 2008
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on June 18, 2013