AlcoholismPhase 2NCT00004552
Acamprosate Treatment: Mechanisms of Action
A Phase 2 study testing acamprosate (Campral) in people with Alcoholism, run by Yale University at 1 site in United States.
Trial summary
This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- acamprosate (Campral)
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2002
- Phase
- Phase 2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for alcohol abuse or dependence.
- Able to read English at 6th grade level or higher and to complete study evaluations.
- Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women.
- No more than 3 days abstinence/week.
Who cannot join
- Current abuse or dependence on other substances, other than nicotine and marijuana.
- Positive test results for opiates, cocaine, benzodiazepines and barbiturates.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Psychiatrically disabled.
- Hepatocellular disease or a history of cirrhosis.
- Medical conditions that would prevent the consumption of alcohol, increase the risk of complicated alcohol withdrawal, or prevent the use of acamprosate such as a history of neurological trauma or disease, seizures, delirium, or hallucinations, hepatic, cardiovascular, metabolic, endocrine, gastrointestinal, or kidney disease.
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- Individuals who have had any significant physical illnesses during the two weeks prior to receiving study medication or during the medication treatment period prior to the withdrawal study.
- Medically detoxified from alcohol more than once within the past five years.
- Alcohol withdrawal symptoms requiring management with benzodiazepines.
- Females who are pregnant, nursing or not using a reliable method of birth control.
- Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past six months.
- Individuals who report disliking spirits and have taken investigational drug or naltrexone within 4 weeks immediately preceding admission to study.
- Individuals who report any daily drug use during the thirty days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation.
- Subjects who have donated blood within the past six weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Unit, University of Connecticut
New Haven, Connecticut, 06511
About this study
Official title: Etiology and Treatment of Alcohol Dependence
This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.
- Conditions
- Alcoholism
- Being tested
- acamprosate (Campral)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acamprosate (Campral)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2000 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Yale 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004552
- Sponsor's protocol ID
- NIAAAOMA03510
- Other IDs
- P50AA003510
- Status last verified
- Jun 2015
- First submitted
- 3 Feb 2000
- Last updated
- 2 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Treatment of Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00004552
- Acronym / sponsor ID
- NIAAAOMA03510
- Conditions
- Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study completion
- Dec 2002
- First posted
- 4 Feb 2000 (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.
This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets criteria for alcohol abuse or dependence.
- Able to read English at 6th grade level or higher and to complete study evaluations.
- Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women.
- No more than 3 days abstinence/week.
Key exclusion criteria (14 listed)
- Current abuse or dependence on other substances, other than nicotine and marijuana.
- Positive test results for opiates, cocaine, benzodiazepines and barbiturates.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Psychiatrically disabled.
- Hepatocellular disease or a history of cirrhosis.
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 |
|---|---|---|
| acamprosate (Campral) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acamprosate (Campral) in people with Alcoholism, run by Yale 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 2 Jul 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Jul 2015.