Clinical trial NCT00330174: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Major Depression
Social Anxiety Disorder
Generalized Anxiety Disorder
Keywords: Alcoholism
Mood
Anxiety
Acamprosate
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
name: Columbia University
First posted: 2006-05-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Days Drinking
timeFrame: 12 weeks
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 12 weeks
measure: Liebowitz Social Anxiety Scale
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University College of Physicians & Surgeons
state: New York
city: Pickens
country: United States
facility: Behavioral Health Services of Pickens County
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Susan C Sonne, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Jennifer S Potter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University College of Physicians & Surgeons
name: Richard Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: