NCT00570219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

3.2 years

First QC Date

December 7, 2007

Last Update Submit

October 16, 2008

Conditions

Substance Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

  • benzodiazepine withdrawal severity

    3 weeks

Secondary Outcomes (2)

  • benzodiazepine use

    4 weeks after treatment

  • attrition from treatment

    3 weeks

Study Arms (2)

B

EXPERIMENTAL

Gradual benzodiazepine discontinuation and valproate treatment

Drug: valproate

A

NO INTERVENTION

Gradual benzodiazepine discontinuation

Interventions

valproateDRUG

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.

Also known as: Deprakine depot
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • History of convulsions
  • Unstable somatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, Uusimaa, 09, Finland

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 10, 2007

Study Start

February 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

FI(1)