Acamprosate vs. Placebo in Bipolar Alcoholics

NCT00466661 | Completed Phase 4 Results

• 1 other identifier: HR#16928
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Acamprosate; Alcoholism; Bipolar disorder; Comorbidity; Craving; Depression; GABA; Glutamate; Mania; Pharmacotherapy; Withdrawal

Outcome Measures

Primary Outcomes (1)

• Time to First Drink (Days)

  Number of days after randomization until consumption of first alcoholic beverage per self-report.

  8 weeks

Secondary Outcomes (8)

• Percent Days Abstinent

  8 weeks

• Percent Heavy Drinking Days

  8 weeks

• Percent Carbohydrate-deficient Transferrin

  8 weeks

• Gamma-glutamyltransferase

  8 weeks

• Obsessive Compulsive Drinking Scale Score

  8 weeks

Study Arms (2)

Acamprosate

EXPERIMENTAL

666 mg p.o. TID

Drug: Acamprosate

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Acamprosate DRUG

666 mg po TID

Acamprosate

Placebo DRUG

2 tabs po TID

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Forest Laboratories: collaborator

Study Sites (1)

Institute of Psychiatry, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism; Bipolar Disorder; Depression; Mania

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Limited sample size

Results Point of Contact

• Title: Bryan K. Tolliver, M.D., Ph.D. (Principal Investigator)
• Organization: Medical University of South Carolina

tollive@musc.edu

(843) 792-4869

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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-12

Locations

US (1)