Alcohol DependencePhase 1/2NCT00330486
Open Label Trial of Acamprosate in Bipolar Alcoholics
A Phase 1/2 study testing Acamprosate in people with Alcohol Dependence and Bipolar Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Bipolar Disorder
- What is being tested?
- Acamprosate
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jun 2007
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18-65
- Meet DSM-IV criteria for current (past 90 days) alcohol dependence
- Meet DSM-IV criteria for bipolar I or bipolar II disorder
- Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
- Must be able to remain free from alcohol for at least 3 days prior to medication initiation
- Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
- Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments
Who cannot join
- Individuals with a primary psychiatric disorder other than bipolar disorder
- Individuals with an uncontrolled neurologic condition that could confound the results of the study
- Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
- Participants with creatine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
- Concomitant use of other psychotropic medications not allowed per the protocol
- Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
- Current suicidal or homicidal risk
- Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25 on the Young Mania Rating Scale
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder
The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.
- Conditions
- Alcohol Dependence, Bipolar Disorder
- Being tested
- Acamprosate
- Keywords
- Acamprosate, Addiction, Alcoholism, Alcohol dependence, Bipolar disorder, Depression, Impulsivity, Mania, Substance abuse
- Medical subject headings
- Alcoholism, Bipolar Disorder, Behavior, Addictive, Depression, Impulsive Behavior, Mania, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use as determined by the time-line follow-back instrument
Secondary outcomes (1)
Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionJun 2007
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 Medical University of South CarolinaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Bryan K. Tolliver, M.D., Ph.D., Principal investigator, Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South CarolinaKathleen T. Brady, M.D., Ph.D., Study director, Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330486
- Sponsor's protocol ID
- HR15882
- Other IDs
- 5K24DA000435-08
- Status last verified
- Sep 2008
- First submitted
- 25 May 2006
- Last updated
- 19 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00330486
- Acronym / sponsor ID
- HR15882
- Conditions
- Alcohol Dependence, Bipolar Disorder
- Keywords
- Acamprosate, Addiction, Alcoholism, Alcohol dependence, Bipolar disorder, Depression, Impulsivity, Mania
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 26 May 2006 (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.
The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ages 18-65
- Meet DSM-IV criteria for current (past 90 days) alcohol dependence
- Meet DSM-IV criteria for bipolar I or bipolar II disorder
- Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
- Must be able to remain free from alcohol for at least 3 days prior to medication initiation
Key exclusion criteria (8 listed)
- Individuals with a primary psychiatric disorder other than bipolar disorder
- Individuals with an uncontrolled neurologic condition that could confound the results of the study
- Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
- Participants with creatine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
- Concomitant use of other psychotropic medications not allowed per the protocol
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 | Drug | – |
Primary outcome
Alcohol use as determined by the time-line follow-back instrument
1 secondary outcome
Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale
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 19 Sep 2008.
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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.
Bryan K. Tolliver, M.D., Ph.D. principal investigator
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Kathleen T. Brady, M.D., Ph.D. study director
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acamprosate in people with Alcohol Dependence and Bipolar Disorder, run by Medical University of South Carolina 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 7 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: finished, as of the sponsor's last update on 19 Sep 2008. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Alcohol use as determined by the time-line follow-back instrument. 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 19 Sep 2008.