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The Effect of Valproate on Benzodiazepine Withdrawal Severity

Information source: Helsinki University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Substance Withdrawal Syndrome

Intervention: valproate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Helsinki University

Official(s) and/or principal investigator(s):
Helena Vorma, MD, Ph.D, Principal Investigator, Affiliation: Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry
Katila Heikki, Md, Ph.D, Study Director, Affiliation: Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: benzodiazepine withdrawal severity

Secondary outcome:

benzodiazepine use

attrition from treatment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence, Helsinki, Uusimaa 09, Finland
Additional Information

Starting date: February 2005
Last updated: October 16, 2008

Page last updated: August 23, 2015

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