Acamprosate in Alcoholics With Comorbid Anxiety or Depression - Full Text View

Sponsors and Collaborators:	Medical University of South Carolina Mclean Hospital Columbia University
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00330174

Purpose

STUDY OBJECTIVES:

The primary objective of this study is to compare the safety and efficacy of acamprosate versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate treatment on mood and anxiety disorders.

STUDY DESIGN:

This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety disorders. The active study phase will be 12 weeks in duration. There will be a two-week screening period, followed by 12 weeks of study medication and a follow-up assessment at 14 weeks from randomization.

STUDY POPULATION:

A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social anxiety will be recruited to participate in this study. Only those individuals whose psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites will participate in this trial.

TREATMENTS:

Eligible participants will be randomly assigned to receive either acamprosate or matching placebo for 12 weeks.

EFFICACY ASSESSEMENTS:

The primary efficacy outcome measure will be cumulative days abstinent as measured by self-report.

Condition	Intervention	Phase
Alcohol Dependence Major Depression Social Anxiety Disorder Generalized Anxiety Disorder	Drug: Acamprosate	Phase IV

MedlinePlus related topics: Alcoholism Anxiety Depression

Drug Information available for: Acamprosate Acamprosate calcium Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Total days abstinent from alcohol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MADRS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Liebowitz Social Anxiety Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Acamprosate tablets	Drug: Acamprosate 2 333mg tablets three times daily
2: Placebo Comparator Matching placebo tablets	Drug: Acamprosate 2 333mg tablets three times daily

Detailed Description:

Participants who meet all inclusion criteria and none of the exclusion criteria will be randomized to receive either acamprosate or placebo in a 1:1 ratio. Participants will be instructed to take (2) 333 mg tablets three times a day. Participants will be seen weekly for 12 weeks an again 14 weeks from randomization. At each weekly visit, participants will be asked about substance use and possible adverse events. They will also have their vital signs and weight measured at each visit. Psychiatric assessments, including the MADRS,HAM-A, Liebowitz Social Anxiety Scale, and Hospital Anxiety and Depression Scale will be performed at weeks 2, 4, 8, and 12. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale at baseline and monthly. A urine drug screen will also be performed monthly. A clinical global impressions scale will be completed for both psychiatric and alcohol abuse symptoms at every visit. A breath alcohol test will be performed at every visit, and a urine drug screen will be performed at baseline and monthly during the trial.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults ages 18-60
Meet DSM-IV criteria for current (past 90 days) alcohol dependence
Must identify alcohol as the primary substance of abuse
Meet DSM-IV criteria for a current major depressive episode, GAD and/or social anxiety disorder
Have a stable psychiatric condition, as evidenced by a baseline CGI change score of 4 or below between the time of initial screening and the baseline visit, and if receiving psychotropic medication, must have a stable dose of medication for at least one month prior to baseline.
Must have a negative urine drug screen at the baseline visit; UDS may be repeated no more that twice to obtain an negative UDS
May be receiving medication treatment for anxiety/mood disorder as long as the dosage has been stable for 4 weeks prior to randomization.
May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety disorders.
Must abstain from alcohol for at least 3 consecutive days but no more than 21 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, be willing to commit to medication treatment and follow-up assessments
CIWA-Ar scale is 8 or less at the baseline visit

Exclusion Criteria:

Individuals with a primary psychotic disorder or bipolar disorder
Individuals who meet DSM-IV criteria for current (past 90 days) dependence on substances other than alcohol, caffeine or nicotine
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
Regular use of benzodiazepines for the treatment of psychiatric symptoms (as defined as more than 12 times in the month prior to the screening visit)
Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention of alcohol relapse
Women of childbearing potential who are lactating or refuse to use adequate forms of birth control
Current suicidal or homicidal risk

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330174

Contacts

Contact: Susan C Sonne, PharmD, BCPP	843.792.5221	sonnesc@musc.edu
Contact: Clare Tyson, MS	843.792.1534	tysonc@musc.edu

Locations

United States, Massachusetts
McLean Hospital	Not yet recruiting
Belmont, Massachusetts, United States, 02478
Principal Investigator: Jennifer S Potter, PhD, MPH
United States, New York
Columbia University College of Physicians & Surgeons	Not yet recruiting
New York, New York, United States, 10025
Contact: Eva M Kourniotis, MS 718-470-8893 kournio@pi.cpmc.columbia.edu
Principal Investigator: Richard Rosenthal, MD
United States, South Carolina
Behavioral Health Services of Pickens County	Recruiting
Pickens, South Carolina, United States, 29671
Contact: Elizabeth Chapman 864-898-5800 becbhspc@bellsouth.net
Sub-Investigator: Robert Hiott, MEd

Sponsors and Collaborators

Medical University of South Carolina

Mclean Hospital

Columbia University

Investigators

Principal Investigator:	Susan C Sonne, PharmD, BCPP	Medical University of South Carolina
Principal Investigator:	Jennifer S Potter, PhD	Mclean Hospital
Principal Investigator:	Richard Rosenthal, MD	Columbia University College of Physicians & Surgeons

More Information

Study ID Numbers:	CMP-MD-04
Study First Received:	May 25, 2006
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00330174
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

Alcoholism
Mood
Anxiety
Acamprosate

Study placed in the following topic categories:

Depression
Disorders of Environmental Origin
Depressive Disorder, Major
Depressive Disorder
Phobic Disorders
Acamprosate
Behavioral Symptoms

Anxiety Disorders
Mental Disorders
Alcoholism
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses

Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 15, 2009