NCT00202514

Brief Summary

The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

September 12, 2005

Last Update Submit

October 7, 2009

Conditions

AlcoholismAlcohol Related DisordersMood Disorders

Keywords

alcoholismalcohol related disordersmood disordersanticonvulsantsdivalproex sodium

Outcome Measures

Primary Outcomes (1)

  • mood and anxiety symptoms over time [SCL-90-R (Symptom Check List)].

Secondary Outcomes (9)

  • scores on additional measures of depression (Ham-D),

  • scores on additional measures of anxiety (Ham-A),

  • scores on additional measures of irritability (AIAQ),

  • Alcohol and other drug consumption (timeline followback),

  • urine toxicology,

  • +4 more secondary outcomes

Interventions

divalproex sodium extended releaseDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or non-pregnant or nursing female age 18 to 65 years old.
  • Females of childbearing potential must agree to practice an acceptable form of birth control during the time enrolled in the study.
  • Diagnosis of DSM-IV alcohol dependence (DSM-IV checklist).
  • Sub-syndromal mood and/or anxiety symptoms (threshold score of 1 standard deviation above the mean for non-psychiatric population on the anxiety, depression, hostility, or global severity subscales of the SCL-90).
  • Subjects must be able to understand and sign an informed consent approved by the center's Institutional Review Board.

You may not qualify if:

  • Opioid dependence as the primary substance diagnosis.
  • Clearly established non-substance related psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV (SCID-IV) requiring immediate medication treatment.
  • Concurrent need for ongoing treatment with a benzodiazepine, anticonvulsants, or medications with significant drug-drug interaction with DVP.
  • Severe liver disease (ascites, jaundice, encephalopathy) suggested by physical exam.
  • AST or ALT \> 200 U/L; total bilirubin \> 2.5 mg/dl.
  • PT \> 1.5X normal.
  • Platelet count \< 100,000/cubic mm, or WBC \< 3,000/cubic mm.
  • Pancreatitis (clinical signs and symptoms, not solely based on blood tests).
  • Known allergy to DVP or valproic acid.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (3)

  • Brady KT, Myrick H, Henderson S, Coffey SF. The use of divalproex in alcohol relapse prevention: a pilot study. Drug Alcohol Depend. 2002 Aug 1;67(3):323-30. doi: 10.1016/s0376-8716(02)00105-9.

    PMID: 12127203BACKGROUND

  • Hertzman M. Divalproex sodium to treat concomitant substance abuse and mood disorders. J Subst Abuse Treat. 2000 Jun;18(4):371-2. doi: 10.1016/s0740-5472(99)00080-x.

    PMID: 10812311BACKGROUND

  • Reoux JP, Saxon AJ, Malte CA, Baer JS, Sloan KL. Divalproex sodium in alcohol withdrawal: a randomized double-blind placebo-controlled clinical trial. Alcohol Clin Exp Res. 2001 Sep;25(9):1324-9.

    PMID: 11584152BACKGROUND

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersMood Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Joseph P Reoux, MD

    Veterans Affairs and University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

US(1)