drugset / Trial / NCT00453804

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI)

NCT00453804

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2006-07
Primary completion
Completion
2007-06

Publications

  • Results Batki, S.L., Dimmock, J.A., Cavallerano, M., Leontieva, L., DeRycke, S., Ploutz-Snyder, R., Gallinger, L., Strutynski, K., Canfield, K., Carey, K.B., Maisto, S.A., Keegan, P., McMaster, T. (under review) (poster presentation) A pilot trial of oral versus long-acting injectable naltrexone in serious mental illness. Research Society on Alcoholism, 30th Annual Scientific Meeting 2007

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule Intramuscular