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 range
18 Years – 64 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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