Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)
Condition: Alcoholism; Alcohol Dependence; Depression
MeSH terms: Alcoholism; Depression
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): naltrexone (Revia); fluoxetine (Prozac)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol Dependence; Depression; Naltrexone; Fluoxetine