Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Alcohol Dependence
MeSH terms: Alcoholism; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goal of this project is to improve the treatment of alcohol dependence in
      patients with serious mental illness (SMI). SMI for this study is defined as any patient with
      any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I
      or type II disorder. Alcohol and other substance use disorders (SUDs) are common among
      individuals with SMI. SUD comorbidity is associated with many adverse consequences. However,
      to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in
      this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence,
      but it has not been systematically applied to the care of patients with SMI. The primary aim
      of this study is to determine the feasibility of long-acting injectable naltrexone
      administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol
      dependence. Secondary aims include providing a preliminary assessment of the tolerability and
      safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of
      alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy
      of long-acting injectable naltrexone in reducing alcohol use from baseline levels.
    

Detailed description: 
      The proposed project is a 1-year pilot program of research, which will examine the
      feasibility of a new, intramuscular (IM) long-acting form of naltrexone. The long-acting form
      of naltrexone may improve medication adherence, which has been shown to be critical to
      successful naltrexone treatment of alcohol dependence. The study is a 16-week, randomized,
      prospective, open-label trial, including a 12-week course of monthly naltrexone injections. A
      follow-up interview will be conducted 4 weeks after discontinuation of medication. Thirty
      subjects will be recruited. Voucher-based incentives will be provided to all subjects to
      ensure attendance for medication administration. Weekly motivational counseling sessions will
      be conducted and will focus on improving motivation to stop alcohol use. Study outcomes
      consist of self-report and biological measures of alcohol use; measures of psychiatric
      symptom severity and neurocognitive functioning; and genetic testing to examine functional
      polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1), which may
      predict response to naltrexone treatment.
    

Intervention name(s): long-lasting injectable naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorders; Schizophrenia; Schizoaffective Disorders; Alcohol Dependence; Long-lasting injectable naltrexone