Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

NCT00006204 | Completed Phase 4

• 1 other identifier: NIAAASAL11929
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism; Alcohol Dependence; Depression

Keywords

Alcoholism; Alcohol Dependence; Depression; Naltrexone; Fluoxetine

Outcome Measures

Primary Outcomes (3)

• Alcohol use as measured by the Timeline

• Follow-back method

• Depressive symptoms as measured by the Hamilton Rating Scale for Depression

Interventions

naltrexone (Revia) DRUG

fluoxetine (Prozac) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Alcoholism; Depression

Interventions

Naltrexone; Fluoxetine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propylamines; Amines; Organic Chemicals

Study Officials

• Ihsan M. Salloum, MD

  Western Psychiatric Institute, Clinic of the University of Pittsburgh Medical Center, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: September 12, 2000
• Study Start: March 1, 2000
• Study Completion: January 1, 2006
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

US (1)