Study of Acamprosate in Driving Under the Influence (DUI) Court Participants (NCT00425711) | Clinical Trial Compass
TerminatedNot Applicable
Study of Acamprosate in Driving Under the Influence (DUI) Court Participants
Stopped: Recruitment barriers.
United States4 participantsStarted 2007-02
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult males and females age 18 - 64 years of age
✓. District Attorney-approved DUI Court participants within 3 months of enrollment into DUI Court
✓. Currently meets DSM-IV criteria for alcohol dependence
✓. Subject agrees to alcohol abstinence as a goal
✓. Women must agree to use an approved method of birth control (tubal ligation, birth control pills, IUD)
✓. Negative UCG (females only)
✓. 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
✓. Must have the ability to comprehend key components of the informed consent and provide consent
Exclusion criteria
✕. History of allergy to acamprosate
✕. Previously failed trial of acamprosate
✕. Pregnancy, lactation, or unprotected intercourse during study period
✕. Lifetime diagnosis of schizophrenia or schizoaffective disorder
✕. 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
✕. Active suicidality, a Beck Depression Inventory II suicide item score of \> 2, or a Beck Depression Inventory II total score \> 15
✕. 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
✕. 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