Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Dependence; Depression
Intervention: naltrexone (Revia) (Drug); fluoxetine (Prozac) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Official(s) and/or principal investigator(s): Ihsan M. Salloum, MD, Principal Investigator, Affiliation: Western Psychiatric Institute, Clinic of the University of Pittsburgh Medical Center, Pittsburgh, PA
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.
Clinical Details
Official title: Combined Pharmacotherapy in Depressed Alcoholics
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Alcohol use as measured by the TimelineFollow-back method Depressive symptoms as measured by the Hamilton Rating Scale for Depression
Detailed description:
We propose to test the efficacy of the combination of naltrexone and fluoxetine versus
fluoxetine alone in the treatment of patients with alcoholism and co-morbid major depression
in a double-blind, placebo- controlled, randomized, parallel group trial. With nearly eight
million affected individuals in the U. S., co-morbid alcoholism and major depressive disorder
represent a significant public health problem. The presence of co-morbidity has a
significant negative impact on treatment response and outcome, resulting in increased risk
for suicide and increased rates of costly inpatient psychiatric care. Effective
pharmacologic treatments addressing thee dual disorders are lacking. Only partial response
has been obtained in studies evaluating anti- depressant monotherapy in depressed
alcoholics. Our previous work with the SSRI fluoxetine has demonstrative the positive
results published to date in severely depressed alcoholics. Our previous work with the SSRI
fluoxetine has demonstrative the most positive results published to date in severely
depressed alcoholics. The fluoxetine group in that study, however, displayed only a partial
treatment response, with low abstinence rates and persistent depressive symptoms and alcohol
abuse. However, our original and extended pilot work evaluating the usefulness of combined
naltrexone and fluoxetine suggest a robust response, with a significant decrease in alcohol
use and depressive symptoms. Our study of potential interactions between these two
medications documents that naltrexone does not increase fluoxetine or norfluoxetine blood
levels in most patients. Our proposed study will build on our previous work and established
record both in conducting medication efficacy trials in this complex and high risk
population, and in developing fundamental pharmacological methodologies necessary to
investigate the proposed rug interaction studies. The timeliness of our proposed study is
underscored by the high prevalence of this co-morbid condition and by the widely but
untested use of the combined medication treatment in clinical practice. Thus, our study our
will fill an important gap in our knowledge regarding the treatment of high risk clinical
population. We hypothesize that combined fluoxetine and naltrexone treatment will offer
enhanced treatment for alcoholics with co-morbid major depression. While the fluoxetine will
target the depressive disorders in addition to the compulsive consumatory behavior related
to alcoholism, the naltrexone will target the positive reinforcing effect and release risk
related to pathological alcohol use. We request five years of support to achieve the
following aims: 1) Examine the efficacy of naltrexone plus fluoxetine compared to fluoxetine
and placebo in the treatment of patients with co- morbid DSM-IV alcohol dependence and
unipolar major depression.; 2) Assess specific predictors of medication response; 3) Conduct
a prospective assessment of the effect of persistent depressive symptoms on alcohol use. One
hundred and six acutely depressed and actively drinking subjects will be randomized and
prospectively followed during a 6 month double-blind study, and a 6-month post-treatment
follow-up phase.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: March 2000
Last updated: December 7, 2007
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