Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
State University of New York - Upstate Medical University