Alcohol DependencePhase 4NCT00466661
Acamprosate vs. Placebo in Bipolar Alcoholics
A Phase 4 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
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2010
- 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 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, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
- 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 creatinine 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: A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.
The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
- Conditions
- Alcohol Dependence, Bipolar Disorder
- Being tested
- Acamprosate, Placebo
- Keywords
- Acamprosate, Alcoholism, Bipolar disorder, Comorbidity, Craving, Depression, GABA, Glutamate, Mania, Pharmacotherapy, Withdrawal
- Medical subject headings
- Alcoholism, Bipolar Disorder, Depression, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
666 mg po TID
PlaceboDrug
2 tabs po TID
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Experimental | 666 mg p.o. TID Receives: Drug: Acamprosate |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Drink (Days)
Number of days after randomization until consumption of first alcoholic beverage per self-report.
Measured: 8 weeks
Secondary outcomes (8)
Percent Days Abstinent
Percentage of days in trial with no alcohol consumption
Measured: 8 weeks
Percent Heavy Drinking Days
Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)
Measured: 8 weeks
Percent Carbohydrate-deficient Transferrin
Measured level of validated serum alcohol biomarker
Measured: 8 weeks
Gamma-glutamyltransferase
Measured levels of validated serum alcohol biomarker
Measured: 8 weeks
Obsessive Compulsive Drinking Scale Score
Higher scores indicate worse outcome; minimum score = 0, maximum score = 40
Measured: 8 weeks
Montgomery Asberg Depression Rating Scale Score
MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Measured: 8 weeks
Young Mania Rating Scale Score
YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Measured: 8 weeks
Clinical Global Impression Scale Score
Higher values indicate worse outcomes; minimum value = 1, maximum value = 7
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- 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
- NCT00466661
- Sponsor's protocol ID
- HR#16928
- Status last verified
- Dec 2018
- First submitted
- 25 Apr 2007
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00466661
- Acronym / sponsor ID
- HR#16928
- Conditions
- Alcohol Dependence, Bipolar Disorder
- Keywords
- Acamprosate, Alcoholism, Bipolar disorder, Comorbidity, Craving, Depression, GABA, Glutamate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.
The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acamprosate | Experimental | Drug: Acamprosate666 mg p.o. TID |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
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, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
- 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 creatinine 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 |
|---|---|---|
| Acamprosate666 mg po TID | Drug | Acamprosate |
| Placebo2 tabs po TID | Drug | Placebo |
Primary outcome
Time to First Drink (Days)
Time frame: 8 weeks
Number of days after randomization until consumption of first alcoholic beverage per self-report.
8 secondary outcomes
Percent Days Abstinent
Time frame: 8 weeks
Percent Heavy Drinking Days
Time frame: 8 weeks
Percent Carbohydrate-deficient Transferrin
Time frame: 8 weeks
Gamma-glutamyltransferase
Time frame: 8 weeks
Obsessive Compulsive Drinking Scale Score
Time frame: 8 weeks
Montgomery Asberg Depression Rating Scale Score
Time frame: 8 weeks
Young Mania Rating Scale Score
Time frame: 8 weeks
Clinical Global Impression Scale Score
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- 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.
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 4 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 14 Dec 2018. 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. Some participants in this study may receive a placebo. 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 14 Dec 2018). 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?
Time to First Drink (Days) (time frame: 8 weeks). 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 14 Dec 2018.