Acamprosate in Alcoholics With Comorbid Anxiety or Depression



Status:Completed
Conditions:Anxiety, Depression, Healthy Studies, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:April 2006
End Date:December 2008
Contact:Susan C Sonne, PharmD, BCPP
Email:sonnesc@musc.edu
Phone:843.792.5221

Use our guide to learn which trials are right for you!

The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression


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.


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.

Inclusion Criteria:

1. Adults ages 18-60

2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence

3. Must identify alcohol as the primary substance of abuse

4. Meet DSM-IV criteria for a current major depressive episode, GAD and/or social
anxiety disorder

5. 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.

6. Must have a negative urine drug screen at the baseline visit; UDS may be repeated no
more that twice to obtain an negative UDS

7. May be receiving medication treatment for anxiety/mood disorder as long as the dosage
has been stable for 4 weeks prior to randomization.

8. May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety
disorders.

9. Must abstain from alcohol for at least 3 consecutive days but no more than 21 days
prior to medication initiation

10. 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

11. Subjects must consent to random assignment, be willing to commit to medication
treatment and follow-up assessments

12. CIWA-Ar scale is 8 or less at the baseline visit

Exclusion Criteria:

1. Individuals with a primary psychotic disorder or bipolar disorder

2. Individuals who meet DSM-IV criteria for current (past 90 days) dependence on
substances other than alcohol, caffeine or nicotine

3. Individuals with an uncontrolled neurologic condition that could confound the results
of the study

4. Individuals with an uncontrolled medical condition that may adversely affect the
conduct of this trial or jeopardize the subject's safety

5. 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)

6. Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention
of alcohol relapse

7. Women of childbearing potential who are lactating or refuse to use adequate forms of
birth control

8. Current suicidal or homicidal risk
We found this trial at
3
sites
Pickens, South Carolina 29671
?
mi
from
Pickens, SC
Click here to add this to my saved trials
115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
?
mi
from
Belmont, MA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials