Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Fluoxetine; Naltrexone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.