Alcohol DependencePhase 4NCT00249379
Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees
A Phase 4 study testing Acamprosate in people with Alcohol Dependence, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of alcohol dependence in the year before entering criminal justice supervision
- Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia
Who cannot join
- Pregnant or nursing a baby
- Known sensitivity to acamprosate
- Elevated serum creatinine level or other evidence of kidney problems
- Symptoms of severe depression or suicidal ideation
- Non-English speaking such that they cannot provide informed consent
- Cognitive impairment such that they cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
About this study
Official title: The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).
Read the detailed description
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.
Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.
- Conditions
- Alcohol Dependence
- Being tested
- Acamprosate
- Keywords
- Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Also called Campral
Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Experimental | Subjects randomized to receive acamprosate Receives: Drug: Acamprosate |
| No medication | No intervention | No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking and Other Drug Use
Number of participants using alcohol and other drugs during 12 weeks
Measured: 12 weeks
Level of Acceptance
Number of participants taking study medication during 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Retention in Drug Court
Number of participants remaining in drug treatment court program during 12 weeks
Measured: 12 weeks
Recidivism Rates
Number of participants returning to jail during 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Not enough sugjects enrolled before funding ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Michael F. Weaver, MD, Principal investigator, Virginia Commonwealth University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249379
- Sponsor's protocol ID
- NIAAAWEA-K23-00222-B
- Other IDs
- K23AA000222
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2005
- Last updated
- 11 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
- ClinicalTrials.gov ID
- NCT00249379
- Acronym / sponsor ID
- NIAAAWEA-K23-00222-B
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough sugjects enrolled before funding ran out
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 11 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).
Detailed description
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.
Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acamprosate | Experimental | Drug: AcamprosateSubjects randomized to receive acamprosate |
| No medication | No intervention | –No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of alcohol dependence in the year before entering criminal justice supervision
- Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia
Key exclusion criteria (6 listed)
- Pregnant or nursing a baby
- Known sensitivity to acamprosate
- Elevated serum creatinine level or other evidence of kidney problems
- Symptoms of severe depression or suicidal ideation
- Non-English speaking such that they cannot provide informed consent
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: CampralSubjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence | Drug | Acamprosate |
Primary outcome
Drinking and Other Drug Use
Time frame: 12 weeks
Number of participants using alcohol and other drugs during 12 weeks
Level of Acceptance
Time frame: 12 weeks
Number of participants taking study medication during 12 weeks
2 secondary outcomes
Retention in Drug Court
Time frame: 12 weeks
Recidivism Rates
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael F. Weaver, MD principal investigator
Virginia Commonwealth University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acamprosate in people with Alcohol Dependence, run by Virginia Commonwealth University 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 2 inclusion and 6 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 11 May 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Drinking and Other Drug Use (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 11 May 2016.