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Acamprosate in Alcoholics With Comorbid Anxiety or Depression

Primary Purpose

Alcohol Dependence, Major Depression, Social Anxiety Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcoholism, Mood, Anxiety, Acamprosate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital
  • Columbia University College of Physicians & Surgeons
  • Behavioral Health Services of Pickens County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Acamprosate tablets

Matching placebo tablets

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.
Liebowitz Social Anxiety Scale
The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.
Hospital Anxiety and Depression Scale
This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.

Full Information

First Posted
May 25, 2006
Last Updated
April 10, 2015
Sponsor
Medical University of South Carolina
Collaborators
Mclean Hospital, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00330174
Brief Title
Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Official Title
The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Mclean Hospital, Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Major Depression, Social Anxiety Disorder, Generalized Anxiety Disorder
Keywords
Alcoholism, Mood, Anxiety, Acamprosate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Acamprosate tablets
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Intervention Description
2 333mg tablets three times daily
Primary Outcome Measure Information:
Title
Percent Days Drinking
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.
Time Frame
12 weeks
Title
Liebowitz Social Anxiety Scale
Description
The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale
Description
This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan C Sonne, PharmD, BCPP
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer S Potter, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Rosenthal, MD
Organizational Affiliation
Columbia University College of Physicians & Surgeons
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Columbia University College of Physicians & Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Behavioral Health Services of Pickens County
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States

12. IPD Sharing Statement

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Acamprosate in Alcoholics With Comorbid Anxiety or Depression

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