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The Effect of Valproate on Benzodiazepine Withdrawal Severity

NCT ID: NCT00570219

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance Withdrawal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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B

Gradual benzodiazepine discontinuation and valproate treatment

Group Type EXPERIMENTAL

valproate

Intervention Type 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.

A

Gradual benzodiazepine discontinuation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Deprakine depot

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Helsinki University Central Hospital, Department of Psychiatry

Principal Investigators

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Helena Vorma, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry

Katila Heikki, Md, Ph.D

Role: STUDY_DIRECTOR

Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry

Locations

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

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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KLnro47/2005

Identifier Type: -

Identifier Source: secondary_id

PS05BENVAL

Identifier Type: -

Identifier Source: org_study_id