Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Alcohol Dependence, Major Depression, Social Anxiety Disorder
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcoholism, Mood, Anxiety, Acamprosate
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
Sites / Locations
- McLean Hospital
- Columbia University College of Physicians & Surgeons
- Behavioral Health Services of Pickens County
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Acamprosate tablets
Matching placebo tablets