Study of Acamprosate in Driving Under the Influence (DUI) Court Participants

Sponsor

University of Oklahoma (Other)

Overall Status

Terminated

CT.gov ID

NCT00425711

Collaborator

Forest Laboratories (Industry)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Drug: Acamprosate	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study of Acamprosate in DUI Court Participants

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DUI Court Participants Individuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate.	Drug: Acamprosate Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks Other Names: Campral

Arm

Intervention/Treatment

Experimental: DUI Court Participants

Individuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate.

Drug: Acamprosate

Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks

Other Names:

Campral

Outcome Measures

Primary Outcome Measures

time until relapse, i.e. any alcohol consumption [Baseline and weeks 2, 4, 8, and 12]

Secondary Outcome Measures

Admission to residential treatment or jail [baseline and weeks 2, 4, 8, and 12]
Depressive symptoms as measured by the Beck Depression Inventory II [baseline and weeks 2, 4, 8, and 12]
Anxiety symptoms as measured by the Beck Anxiety Inventory [baseline and weeks 2, 4, 8, and 12]
Penn Alcohol Craving Scale scores [baseline and weeks 2, 4, 8, and 12]
Obsessive Compulsive Drinking Scale scores [baseline and weeks 2, 4, 8, and 12]
Adverse events [baseline and weeks 2, 4, 8, and 12]
Proportion of days on which alcohol was consumed [baseline and weeks 2, 4, 8, and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Current score of 15 or less on the Beck Depression Inventory II
Subject has undergone detoxification and is currently abstinent from alcohol

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