Alcohol DependenceNCT00425711
Study of Acamprosate in Driving Under the Influence (DUI) Court Participants
A study testing Acamprosate in people with Alcohol Dependence, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Acamprosate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma, Tulsa
Tulsa, Oklahoma, 74135
About this study
Official title: An Open-Label Study of Acamprosate in DUI Court Participants
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.
Read the 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.
- Conditions
- Alcohol Dependence
- Being tested
- Acamprosate
- Keywords
- Acamprosate, Alcohol Dependence, Driving Under the Influence, Drug Court, DUI Court
- Medical subject headings
- Alcoholism, Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Also called Campral
Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| DUI Court Participants | Experimental | Individuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate. Receives: Drug: Acamprosate |
What is being measured
The primary outcome is the main question the study is designed to answer.
time until relapse, i.e. any alcohol consumption
Measured: Baseline and weeks 2, 4, 8, and 12
Secondary outcomes (7)
Admission to residential treatment or jail
Measured: baseline and weeks 2, 4, 8, and 12
Depressive symptoms as measured by the Beck Depression Inventory II
Measured: baseline and weeks 2, 4, 8, and 12
Anxiety symptoms as measured by the Beck Anxiety Inventory
Measured: baseline and weeks 2, 4, 8, and 12
Penn Alcohol Craving Scale scores
Measured: baseline and weeks 2, 4, 8, and 12
Obsessive Compulsive Drinking Scale scores
Measured: baseline and weeks 2, 4, 8, and 12
Adverse events
Measured: baseline and weeks 2, 4, 8, and 12
Proportion of days on which alcohol was consumed
Measured: baseline and weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Recruitment barriers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Julia K Warnock, M.D., Ph.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425711
- Sponsor's protocol ID
- Warnock_Acamprosate-P
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2007
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Acamprosate in DUI Court Participants
- ClinicalTrials.gov ID
- NCT00425711
- Acronym / sponsor ID
- Warnock_Acamprosate-P
- Conditions
- Alcohol Dependence
- Keywords
- Acamprosate, Alcohol Dependence, Driving Under the Influence, Drug Court, DUI Court
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment barriers.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DUI Court Participants | Experimental | Drug: AcamprosateIndividuals enrolled in the DUI Court treatment site will be recruited for the 13 week open-label trial of acamprosate. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcamprosateAlso: CampralAcamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks | Drug | DUI Court Participants |
Primary outcome
time until relapse, i.e. any alcohol consumption
Time frame: Baseline and weeks 2, 4, 8, and 12
7 secondary outcomes
Admission to residential treatment or jail
Time frame: baseline and weeks 2, 4, 8, and 12
Depressive symptoms as measured by the Beck Depression Inventory II
Time frame: baseline and weeks 2, 4, 8, and 12
Anxiety symptoms as measured by the Beck Anxiety Inventory
Time frame: baseline and weeks 2, 4, 8, and 12
Penn Alcohol Craving Scale scores
Time frame: baseline and weeks 2, 4, 8, and 12
Obsessive Compulsive Drinking Scale scores
Time frame: baseline and weeks 2, 4, 8, and 12
Adverse events
Time frame: baseline and weeks 2, 4, 8, and 12
Proportion of days on which alcohol was consumed
Time frame: baseline and weeks 2, 4, 8, and 12
Results and safety
The study was stopped early (reason given: Recruitment barriers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia K Warnock, M.D., Ph.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acamprosate in people with Alcohol Dependence, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment barriers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time until relapse, i.e. any alcohol consumption (time frame: Baseline and weeks 2, 4, 8, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.