Overview

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

Status:
Terminated

Trial end date:
2009-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Oklahoma

Collaborator:

Forest Laboratories

Treatments:

Acamprosate

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