NCT00425711

Brief Summary

Acamprosate will be given to approximately 30 DUI Court participants for 3 months and outcomes will be monitored. The hypothesis is that acamprosate will be safe and well-tolerated and that subjects' craving and other symptoms related to addiction will improve over time.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

January 22, 2007

Last Update Submit

July 26, 2012

Conditions

Alcohol Dependence

Keywords

AcamprosateAlcohol DependenceDriving Under the InfluenceDrug CourtDUI Court

Outcome Measures

Primary Outcomes (1)

  • time until relapse, i.e. any alcohol consumption

    Baseline and weeks 2, 4, 8, and 12

Secondary Outcomes (7)

  • Admission to residential treatment or jail

    baseline and weeks 2, 4, 8, and 12

  • Depressive symptoms as measured by the Beck Depression Inventory II

    baseline and weeks 2, 4, 8, and 12

  • Anxiety symptoms as measured by the Beck Anxiety Inventory

    baseline and weeks 2, 4, 8, and 12

  • Penn Alcohol Craving Scale scores

    baseline and weeks 2, 4, 8, and 12

  • Obsessive Compulsive Drinking Scale scores

    baseline and weeks 2, 4, 8, and 12

  • +2 more secondary outcomes

Study Arms (1)

DUI Court Participants

EXPERIMENTAL

Individuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate.

Drug: Acamprosate

Interventions

AcamprosateDRUG

Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks

Also known as: Campral
DUI Court Participants

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males and females age 18 - 64 years of age
  • District Attorney-approved DUI Court participants within 3 months of enrollment into DUI Court
  • Currently meets DSM-IV criteria for alcohol dependence
  • Subject agrees to alcohol abstinence as a goal
  • Women must agree to use an approved method of birth control (tubal ligation, birth control pills, IUD)
  • Negative UCG (females only)
  • Treatment with an MAOI, other antidepressants, antipsychotics, anticonvulsants, mood stabilizers, or Saint John's Wort are permissible if subject has been on a stable dose for 3 months
  • Must have the ability to comprehend key components of the informed consent and provide consent
  • Current score of 15 or less on the Beck Depression Inventory II
  • Subject has undergone detoxification and is currently abstinent from alcohol

You may not qualify if:

  • History of allergy to acamprosate
  • Previously failed trial of acamprosate
  • Pregnancy, lactation, or unprotected intercourse during study period
  • Lifetime diagnosis of schizophrenia or schizoaffective disorder
  • Creatinine clearance \<30 mL/minute. If serum creatinine is greater than 1.4 mg/dL then the Cockcroft-Gault equation will be used to estimate creatinine clearance
  • Active suicidality, a Beck Depression Inventory II suicide item score of \> 2, or a Beck Depression Inventory II total score \> 15
  • Any unstable medical condition which, in the opinion of the investigator, is considered clinically significant or could affect the subject's safety or ability to complete the study
  • Use of a benzodiazepine or other sedative-hypnotic agent (including kava kava or valerian), except for eszopiclone, zaleplon, or zolpidem \< 3 times weekly over the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Oklahoma, Tulsa

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

AlcoholismDriving Under the Influence

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCriminal BehaviorBehaviorDangerous Behavior

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Julia K Warnock, M.D., Ph.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

US(1)