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Alcohol-Dependence drug studied in DUI offenders – study halted early

NCT ID NCT00425711

Disease control Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called acamprosate in adults with alcohol dependence who were part of a DUI court program. The goal was to see if the medication could help them stay sober and reduce cravings. Only 4 people enrolled before the study was stopped, so results are very limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Start date

Feb 2007

Finished

Dec 2009

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol dependence Driving Under the Influence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol dependence

Contacts and locations

Locations

  • The University of Oklahoma, Tulsa

    Tulsa, Oklahoma, 74135, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.