drugset / Trial / NCT01155869

Pilot Study of Depot NTX in Homeless Veterans

NCT01155869

Phase 4 Terminated 7 enrolled US Department of Veterans Affairs
RandomizedParallel-groupOpen-labelHealth-services research

Summary

Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless adults in the U.S. Half need treatment for a substance use disorder, usually alcohol dependence, but sobriety is often required to access alcohol treatment and housing services. A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but seldom used because of adherence problems that limit effectiveness. This open-label pilot study would compare the effect of depot versus oral naltrexone to help twenty homeless, alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing services. This study's findings could expand access to effective medication-assisted alcohol treatment in the VA, and thus help homeless veterans with alcohol problems improve their drinking, housing status, and appropriate use of health services.

Timeline

Start
2010-08
Primary completion
2011-07
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naltrexone Small molecule 50 mg Oral
Comparator Naltrexone Small molecule 380 mg Intramuscular

Indications