Open Label Trial of Acamprosate in Bipolar Alcoholics
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00330486 |
Recruitment Status :
Completed
First Posted : May 26, 2006
Last Update Posted : September 19, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence Bipolar Disorder | Drug: Acamprosate | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |

- Alcohol use as determined by the time-line follow-back instrument
- Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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, 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
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330486
United States, South Carolina | |
Institute of Psychiatry, Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
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 |
ClinicalTrials.gov Identifier: | NCT00330486 |
Other Study ID Numbers: |
HR15882 5K24DA000435-08 ( U.S. NIH Grant/Contract ) |
First Posted: | May 26, 2006 Key Record Dates |
Last Update Posted: | September 19, 2008 |
Last Verified: | September 2008 |
Acamprosate Addiction Alcoholism Alcohol dependence Bipolar disorder |
Depression Impulsivity Mania Substance abuse |
Alcoholism Bipolar Disorder Bipolar and Related Disorders Mental Disorders Alcohol-Related Disorders |
Substance-Related Disorders Chemically-Induced Disorders Acamprosate Alcohol Deterrents |