Alcohol Dependence Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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