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

This study has been terminated.
(Recruitment barriers.)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00425711
First received: January 22, 2007
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Alcohol Dependence
 Drug: Acamprosate

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Acamprosate in DUI Court Participants

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • time until relapse, i.e. any alcohol consumption [ Time Frame: Baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Admission to residential treatment or jail [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Depressive symptoms as measured by the Beck Depression Inventory II [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: Yes ]
  • Anxiety symptoms as measured by the Beck Anxiety Inventory [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Penn Alcohol Craving Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Obsessive Compulsive Drinking Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: Yes ]
  • Proportion of days on which alcohol was consumed [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425711

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00425711     History of Changes
Other Study ID Numbers: Warnock_Acamprosate
Study First Received: January 22, 2007
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Acamprosate
 Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013