Study of Acamprosate in Driving Under the Influence (DUI) Court Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425711
Recruitment Status : Terminated (Recruitment barriers.)
First Posted : January 23, 2007
Last Update Posted : July 27, 2012
Forest Laboratories
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Acamprosate Not Applicable

Detailed Description:

Purpose: The study is a 13 week open-label study of the use of acamprosate in subjects who have elected to participate in the DUI Court program in Tulsa County. Admission to the DUI Court is completely voluntary. Participants must apply for admission, undergo an initial evaluation, and receive approval by the District Attorney's office and the presiding judge. The four-phase program requires a minimum of 1 year to complete. Each phase requires counseling, mandatory random urine drug screens, mandatory daily breathalyzer tests, a nightly curfew and that the participant be gainfully employed or in school. Currently, approximately 10% of the participants are able to complete the program in the minimum 12 month requirement. The main objective of the study is to evaluate the duration of alcohol abstinence in DUI Court participants receiving acamprosate.

Design: Thirty subjects will be enrolled in the study. New DUI court participants, within 3 months of enrollment, will be invited to participate in the trial. Qualified subjects will receive, in addition to the required DUI court assessments and treatments, a physical examination, baseline safety laboratory, study drug, psychiatric evaluation, depressive and anxiety rating scales, a personality disorder questionnaire and vital signs taken at each visit. Alcohol and substance use will be assessed by self-report and validated with review of the court-ordered laboratory and breathalyzer tests.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Acamprosate in DUI Court Participants
Study Start Date : February 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DUI Court Participants
Individuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate.
Drug: Acamprosate
Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks
Other Name: Campral

Primary Outcome Measures :
  1. time until relapse, i.e. any alcohol consumption [ Time Frame: Baseline and weeks 2, 4, 8, and 12 ]

Secondary Outcome Measures :
  1. Admission to residential treatment or jail [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  2. Depressive symptoms as measured by the Beck Depression Inventory II [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  3. Anxiety symptoms as measured by the Beck Anxiety Inventory [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  4. Penn Alcohol Craving Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  5. Obsessive Compulsive Drinking Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  6. Adverse events [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]
  7. Proportion of days on which alcohol was consumed [ Time Frame: baseline and weeks 2, 4, 8, and 12 ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult males and females age 18 - 64 years of age
  2. District Attorney-approved DUI Court participants within 3 months of enrollment into DUI Court
  3. Currently meets DSM-IV criteria for alcohol dependence
  4. Subject agrees to alcohol abstinence as a goal
  5. Women must agree to use an approved method of birth control (tubal ligation, birth control pills, IUD)
  6. Negative UCG (females only)
  7. 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
  8. Must have the ability to comprehend key components of the informed consent and provide consent
  9. Current score of 15 or less on the Beck Depression Inventory II
  10. Subject has undergone detoxification and is currently abstinent from alcohol

Exclusion Criteria:

  1. History of allergy to acamprosate
  2. Previously failed trial of acamprosate
  3. Pregnancy, lactation, or unprotected intercourse during study period
  4. Lifetime diagnosis of schizophrenia or schizoaffective disorder
  5. 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
  6. Active suicidality, a Beck Depression Inventory II suicide item score of > 2, or a Beck Depression Inventory II total score > 15
  7. 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
  8. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425711

United States, Oklahoma
The University of Oklahoma, Tulsa
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
University of Oklahoma
Forest Laboratories
Principal Investigator: Julia K Warnock, M.D., Ph.D. University of Oklahoma

Responsible Party: University of Oklahoma Identifier: NCT00425711     History of Changes
Other Study ID Numbers: Warnock_Acamprosate
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by University of Oklahoma:
Alcohol Dependence
Driving Under the Influence
Drug Court
DUI Court

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents