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

Summary: 
      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 as compared with oral 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 as
      compared with oral naltrexone in reducing alcohol use from baseline levels
    

Detailed description: 
      The overall goal of this project is to improve the treatment of alcohol abuse and 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, bipolar type I
      disorder, major depressive disorder with psychotic features, or psychotic disorder not
      otherwise specified. Alcohol and other substance use disorders (SUDs) are common among
      individuals with SMI such as schizophrenia. 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. This pilot study plans to use a new intramuscular long-acting form of naltrexone
      that needs to be administered every 4 weeks compared to daily oral naltrexone, which we are
      also studying in this pilot. This could improve adherence to a medication regimen, which has
      been shown to be critical to successful naltrexone treatment of alcohol dependence. The
      proposed project is a 1-year pilot program of research. It is a randomized prospective
      parallel groups open-label trial of long-acting intramuscular (IM) naltrexone injected every
      4 weeks compared to monthly prescriptions of oral naltrexone in a cohort of 20 subjects, ten
      for each treatment modality. The study is 16 weeks in duration, consisting of a 12-week
      course of naltrexone plus one follow-up interview at 4 weeks after discontinuation of
      medication. Voucher-based incentives are provided to all subjects to ensure attendance for
      medication administration. Weekly motivational counseling sessions are conducted and focus on
      improving motivation to stop alcohol use. Study outcomes consist of self-report and
      biological measures of alcohol use as well as measures of psychiatric symptom severity.
    

Intervention name(s): injectable naltrexone; oral naltrexone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol dependence; Major Mental Illness; Injectable naltrexone