Acamprosate in Alcoholics With Comorbid Anxiety or Depression

NCT00330174 | Completed Phase 4 Results

• 1 other identifier: CMP-MD-04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Alcohol Dependence; Major Depression; Social Anxiety Disorder; Generalized Anxiety Disorder

Keywords

Alcoholism; Mood; Anxiety; Acamprosate

Outcome Measures

Primary Outcomes (1)

• Percent Days Drinking

  Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.

  12 weeks

Secondary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  12 weeks

• Liebowitz Social Anxiety Scale

  12 weeks

• Hospital Anxiety and Depression Scale

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Acamprosate tablets

Drug: Acamprosate

2

PLACEBO COMPARATOR

Matching placebo tablets

Drug: Acamprosate

Interventions

Acamprosate DRUG

2 333mg tablets three times daily

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Mclean Hospital: collaborator
• Columbia University: collaborator

Study Sites (3)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Columbia University College of Physicians & Surgeons

New York, New York, 10025, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

MeSH Terms

Conditions

Alcoholism; Depressive Disorder, Major; Phobia, Social; Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Susan Sonne, PharmD, BCPP
• Organization: Medical University of South Carolina

sonnesc@musc.edu

843.792.5221

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 26, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-04

Locations

US (3)