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

Alcohol Dependence Clinical Trial

Official title:

An Open-Label Study of Acamprosate in DUI Court Participants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00425711
• Other study ID #: Warnock_Acamprosate
• Status: Terminated
• Phase: N/A
• First received: January 22, 2007
• Last updated: July 26, 2012
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	The University of Oklahoma, Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time until relapse, i.e. any alcohol consumption		Baseline and weeks 2, 4, 8, and 12	No
Secondary	Admission to residential treatment or jail		baseline and weeks 2, 4, 8, and 12	No
Secondary	Depressive symptoms as measured by the Beck Depression Inventory II		baseline and weeks 2, 4, 8, and 12	Yes
Secondary	Anxiety symptoms as measured by the Beck Anxiety Inventory		baseline and weeks 2, 4, 8, and 12	No
Secondary	Penn Alcohol Craving Scale scores		baseline and weeks 2, 4, 8, and 12	No
Secondary	Obsessive Compulsive Drinking Scale scores		baseline and weeks 2, 4, 8, and 12	No
Secondary	Adverse events		baseline and weeks 2, 4, 8, and 12	Yes
Secondary	Proportion of days on which alcohol was consumed		baseline and weeks 2, 4, 8, and 12	No