The Effect of Valproate on Benzodiazepine Withdrawal Seve... | NCT00570219

Studies
The Effect of Valproate on Benzodiazepine Withdrawal Severity

NCT00570219

Sponsor

University of Helsinki

Status

Completed

Last Update Posted

Oct 17, 2008Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Substance Withdrawal Syndrome

Interventions

valproate

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KLnro47/2005

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 7, 2007

First Submission Date that Met QC Criteria

Dec 7, 2007

First Posted Date

Dec 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Experimental	Gradual benzodiazepine discontinuation and valproate treatment	Drug: valproate
A	No Intervention	Gradual benzodiazepine discontinuation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
valproate	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
benzodiazepine withdrawal severity		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
benzodiazepine use		4 weeks after treatment
attrition from treatment		3 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena Vorma, MD, Ph.D	Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry	Principal Investigator
Katila Heikki, Md, Ph.D	Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence		Helsinki	Uusimaa	09	Finland

Condition Browse Module

MeSH Terms

ID	Term
D013375	Substance Withdrawal Syndrome

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided