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 useattrition 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
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