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

An Open-Label Study of Acamprosate in DUI Court Participants

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Dependence
• Intervention / Treatment: Drug: Acamprosate

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
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • The University of Oklahoma, Tulsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Campral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time until relapse, i.e. any alcohol consumption	Baseline and weeks 2, 4, 8, and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Adverse events	baseline and weeks 2, 4, 8, and 12
Proportion of days on which alcohol was consumed	baseline and weeks 2, 4, 8, and 12

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Julia K Warnock, M.D., Ph.D., University of Oklahoma

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 22, 2007
• First Submitted That Met QC Criteria: January 22, 2007
• First Posted (Estimate): January 23, 2007

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 26, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Alcohol Dependence; Drug Court; Acamprosate; Driving Under the Influence; DUI Court
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Alcohol Deterrents; Acamprosate
• Other Study ID Numbers: Warnock_Acamprosate