Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)
Completed · Phase 4
Conditions studied: Alcoholism, Alcohol Dependence, Depression
In brief
This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.
Key facts
- Study ID
- NCT00006204
- Run by
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- People needed
- 106
- Starts
- 2000-03-01
- Expected to finish
- 2006-01-01
- Last updated by the study team
- 2007-12-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meets criteria for alcohol dependence and comorbid major depressive disorder.
- Absence of any hazardous drinking within 48 to 120 hours (defined as more than or equal to three drinks/day for females and more than or equal to four drinks/day for males).
- No more than 15 days of complete abstinence prior to study.
You may not qualify if…
- Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychiatric disorder, bipolar disorders, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
- Any non-alcohol substance dependence except for nicotine.
- Opioid abuse, opioid dependence, or on opioid maintenance treatment.
- Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalograph examination (EEG).
- Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
- Persistent elevation of liver enzymes indicating active liver disease.
- Females who are pregnant, or unable or unwilling to use reliable birth control methods.
- Unable to read or understand study forms and agree to informed consent.
Where it is running
- Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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