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Report for Clinical Trial NCT00453609

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI): An Open Prospective Pilot Trial

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.

NCT00453609 Schizophrenia Schizoaffective Disorder Bipolar Disorder Alcohol Dependence
MeSH:Disease Alcoholism Schizophrenia Bipolar Disorder Psychotic Disorders
HPO:Bipolar affective disorder Mania Psychosis Schizophrenia

1 Interventions

Name: long-lasting injectable naltrexone

Type: Drug


Primary Outcomes

Measure: feasibility: number recruited, visits attended

Secondary Outcomes

Measure: genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1)

Measure: alcohol use: self-report, biological measures, level of craving.

Measure: psychiatric functioning

Measure: neuropsychological functioning

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 N40D

genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1). --- Asn40Asp ---

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. --- Asn40Asp ---



HPO Nodes


HPO: