NCT00330486

CompletedPhase 1/2

Open Label Trial of Acamprosate in Bipolar Alcoholics

Medical University of South Carolina Source

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Other study identifiers

Sponsor study identifier

HR15882

Secondary identifiers

5K24DA000435-08

NIH

Study Type

interventional

Actual enrollment (reported)

9

Locations

1 country

Sites

1

Timeline

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 9 participants
Study completion date: June 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 25, 2006
Actual (reported)
First Posted
May 26, 2006
Actual (reported)
Primary Completion
June 2007
Actual (reported)
Study Completion
June 2007
Actual (reported)

Last Updated: September 19, 2008
Status Verified: September 2008
Last Update Submitted: September 18, 2008

Conditions

Alcohol Dependence Bipolar Disorder

Keywords

AcamprosateAddictionAlcoholismAlcohol dependenceBipolar disorderDepressionImpulsivityManiaSubstance abuse

Outcome Measures

Primary Outcomes (1)

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

Interventions

AcamprosateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults ages 18-65
Meet DSM-IV criteria for current (past 90 days) alcohol dependence

Sponsors & Collaborators

Medical University of South Carolina
Otherlead

Study Sites (1)

Institute of Psychiatry, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

MeSH Terms

Conditions

AlcoholismBipolar DisorderBehavior, AddictiveDepressionImpulsive BehaviorManiaSubstance-Related Disorders

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental DisordersBipolar and Related DisordersMood DisordersCompulsive Behavior

Study Officials

Bryan K. Tolliver, M.D., Ph.D.
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
PRINCIPAL INVESTIGATOR
Kathleen T. Brady, M.D., Ph.D.
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
STUDY DIRECTOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT00330174

Acamprosate in Alcoholics With Comorbid Anxiety or Depression

Phase 4Completed

NCT00249379

Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Phase 4Terminated

NCT00571922

A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

Phase 1/2Completed

NCT00463346

Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Phase 3Completed

NCT00855699

Alcohol Detoxification in Primary Care Treatment (ADEPT)

Phase 4Completed

NCT00655967

Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)

Phase 4Withdrawn

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Behavior

Behavioral Symptoms

Neurobehavioral Manifestations

Neurologic Manifestations

Nervous System Diseases

Signs and Symptoms

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Last Updated

September 19, 2008

Record last verified: 2008-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00330486
Data provider: ClinicalTrials.gov
Source updated: 2008-09-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:30 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations