Back to results

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

Primary Purpose

Alcohol Dependence

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acamprosate

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Acamprosate, Alcohol Dependence, Driving Under the Influence, Drug Court, DUI Court

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

The University of Oklahoma, Tulsa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DUI Court Participants

Arm Description

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

Outcomes

Primary Outcome Measures

time until relapse, i.e. any alcohol consumption

Secondary Outcome Measures

Admission to residential treatment or jail

Depressive symptoms as measured by the Beck Depression Inventory II

Anxiety symptoms as measured by the Beck Anxiety Inventory

Penn Alcohol Craving Scale scores

Obsessive Compulsive Drinking Scale scores

Adverse events

Proportion of days on which alcohol was consumed

Full Information

NCT ID

NCT00425711

First Posted

January 22, 2007

Last Updated

July 26, 2012

Sponsor

University of Oklahoma

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00425711

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Recruitment barriers.

Study Start Date

February 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

Acamprosate, Alcohol Dependence, Driving Under the Influence, Drug Court, DUI Court

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DUI Court Participants

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Acamprosate

Other Intervention Name(s)

Campral

Intervention Description

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

Primary Outcome Measure Information:

Title

time until relapse, i.e. any alcohol consumption

Time Frame

Baseline and weeks 2, 4, 8, and 12

Secondary Outcome Measure Information:

Title

Admission to residential treatment or jail

Time Frame