Clinical trial NCT00425711: Study of Acamprosate in Driving Under the Influence (DUI) Court Participants
Official title: An Open-Label Study of Acamprosate in DUI Court Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Acamprosate
Alcohol Dependence
Driving Under the Influence
Drug Court
DUI Court
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2007-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: time until relapse, i.e. any alcohol consumption
timeFrame: Baseline and weeks 2, 4, 8, and 12
Secondary outcomes:
measure: Admission to residential treatment or jail
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Depressive symptoms as measured by the Beck Depression Inventory II
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Anxiety symptoms as measured by the Beck Anxiety Inventory
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Penn Alcohol Craving Scale scores
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Obsessive Compulsive Drinking Scale scores
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Adverse events
timeFrame: baseline and weeks 2, 4, 8, and 12
measure: Proportion of days on which alcohol was consumed
timeFrame: baseline and weeks 2, 4, 8, and 12
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: The University of Oklahoma, Tulsa
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Julia K Warnock, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: