Status:
COMPLETED
Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Mclean Hospital
Columbia University
Conditions:
Alcohol Dependence
Major Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 an...
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00330174
Start Date
April 1 2006
End Date
September 1 2010
Last Update
April 13 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
Columbia University College of Physicians & Surgeons
New York, New York, United States, 10025
3
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671