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The Effect of Valproate on Benzodiazepine Withdrawal Severity

Primary Purpose

Substance Withdrawal Syndrome

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

valproate

About this trial

This is an interventional treatment trial for Substance Withdrawal Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Gradual benzodiazepine discontinuation and valproate treatment

Gradual benzodiazepine discontinuation

Outcomes

Primary Outcome Measures

benzodiazepine withdrawal severity

Secondary Outcome Measures

benzodiazepine use

attrition from treatment

Full Information

NCT ID

NCT00570219

First Posted

December 7, 2007

Last Updated

October 16, 2008

Sponsor

University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT00570219

Brief Title

The Effect of Valproate on Benzodiazepine Withdrawal Severity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Helsinki

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Withdrawal Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Gradual benzodiazepine discontinuation and valproate treatment

Arm Title

Arm Type

No Intervention

Arm Description

Gradual benzodiazepine discontinuation

Intervention Type

Drug

Intervention Name(s)

valproate

Other Intervention Name(s)

Deprakine depot

Intervention Description

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.

Primary Outcome Measure Information:

Title

benzodiazepine withdrawal severity

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

benzodiazepine use

Time Frame

4 weeks after treatment

Title

attrition from treatment

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helena Vorma, MD, Ph.D

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Katila Heikki, Md, Ph.D

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

The Effect of Valproate on Benzodiazepine Withdrawal Severity

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