NCT00453804

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

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI): A Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorders
• Schizophrenia
• Schizoaffective Disorders
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	injectable naltrexone
DRUG	oral naltrexone

Timeline

• Start date: 2006-07-01
• Completion: 2007-06-01
• First posted: 2007-03-29
• Last updated: 2008-03-18

Locations

1 site across 1 country: United States