Acamprosate vs. Placebo in Bipolar Alcoholics
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Medical University of South Carolina.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical University of South Carolina
Collaborator:
Forest Laboratories
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00466661
First received: April 25, 2007
Last updated: March 25, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence Bipolar Disorder |
Drug: Acamprosate Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Primary Outcome Measures:
- Percent of days abstinent [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Montgomery Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Young Mania Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Obsessive Compulsive Drinking Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Days until first drink [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Drinks per drinking day [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Percent heavy drinking days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Percent carbohydrate-deficient transferrin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Gamma-glutamyltransferase [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Drinks per week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acamprosate
666 mg p.o. TID
|
Drug: Acamprosate
666 mg po TID
Other Name: Campral
|
|
Placebo Comparator: Placebo
Matching placebo
|
Drug: Placebo
2 tabs po TID
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466661
Locations
| United States, South Carolina | |
| Institute of Psychiatry, Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
Forest Laboratories
Investigators
| Principal Investigator: | Bryan K Tolliver, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina |
| Study Director: | Kathleen T Brady, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00466661 History of Changes |
| Other Study ID Numbers: | HR#16928 |
| Study First Received: | April 25, 2007 |
| Last Updated: | March 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
Acamprosate Alcoholism Bipolar disorder Comorbidity Craving Depression |
GABA Glutamate Mania Pharmacotherapy Withdrawal |
Additional relevant MeSH terms:
|
Alcoholism Bipolar Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Affective Disorders, Psychotic |
Mood Disorders Acamprosate Alcohol Deterrents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013