Status:
COMPLETED
Naltrexone & SSRI in Alcoholics With Depression/PTSD
Lead Sponsor:
Yale University
Conditions:
Alcoholism
Depression
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize t...
Detailed Description
OBJECTIVE: Alcoholics with current comorbid mental disorders constitute the majority of alcoholics in clinical settings. Although there are two FDA approved medications for the treatment of alcoholism...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of alcohol dependence and current DSM-IV depressive disorder or PTSD
- a recent episode of heavy drinking
- outpatient, sober from alcohol and other abused substance for at least 2 days before randomization
- stable medication regiment for at least 2 weeks
- women on adequate methods of contraception
Exclusion
- current opioid dependence or abuse
- history (within the last 3 months) of opioid dependence or abuse
- pregnant
- history of psychotic disorders or current treatment with antipsychotic medications
- medication thought to influence drinking including: acamprosate, disulfiram, naltrexone, ondansetron, valproic acid or tegretol
- current (within the lst 6 months) use of MAO inhibitors
- suicidal active ideation or intent
- significant underlying medical condition
- history of cardiac condition abnormalities
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00338962
Start Date
October 1 2001
End Date
July 1 2015
Last Update
February 5 2016
Active Locations (1)
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1
VA Connecticut Healthcare Systems
West Haven, Connecticut, United States, 06516