Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425711
Status:
TERMINATED
Last Update Posted:
2012-07-27
First Post:
2007-01-22
Brief Title:
Study of Acamprosate in Driving Under the Influence DUI Court Participants
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
An Open-Label Study of Acamprosate in DUI Court Participants
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment barriers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Attorneys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None