Pilot Study of Depot NTX in Homeless Veterans

Anticipated Impacts on Veteran's Healthcare. Ending homelessness among veterans is a major
priority for VA. Veterans represent between one in four and one in three homeless adults.
Almost 200,000 veterans are homeless each night. Rhode Island has the second highest per
capita concentration of homeless persons in the United States and an estimated 2,000
homeless veterans. Half report unmet service needs related to substance use disorders. The
VA is a major service provider to homeless persons and has developed innovative housing
assistance programs. However, sobriety is required to access many housing services.
Effective medication-assisted treatment for the alcohol-dependent, homeless population could
improve their substance use, health care utilization and housing stability. If depot
naltrexone is a useful tool for engaging alcohol-dependent, homeless veterans in effective
treatment, a definitive study showing its effect would lead to fewer restrictions on depot
naltrexone on the VA formulary, and expand access to effective medication-assisted
treatment.

Project Background/Rationale. A dearth of residential long-term rehabilitation beds makes an
initial period of sobriety necessary in order for homeless persons to access needed
transitional sheltering in order to participate in outpatient alcohol treatment. Many
alcohol-dependent homeless veterans find it difficult to achieve a period of sobriety.
Clinical trials suggest that depot naltrexone is more efficacious than placebo in improving
alcohol consumption among alcohol-dependent subjects, but depot naltrexone is expensive and
has limited availability in many VA Medical Centers. Oral naltrexone is widely available
but seldom used. This work seeks to examine the effect of depot versus oral naltrexone to
help homeless alcohol dependent veterans.

Project Objectives. This open-label pilot study will compare the effect of 16-weeks of
depot versus oral naltrexone among housing-seeking, alcohol dependent, homeless veterans.
Outcomes will include alcohol consumption, housing stability, emergency department and
hospital utilization, and substance abuse treatment participation. These preliminary data
will evaluate the feasibility and effect size to allow the design of a larger, more
definitive study of whether, compared to the oral naltrexone condition, the depot naltrexone
group will experience: greater proportion of days abstinent and fewer drinks per drinking
day; shorter time to achieve 30 days sobriety; more improvement in housing stability; fewer
emergency department visits and hospitalizations and greater attendance at substance abuse
treatment (number of visits attended).

Project Methods. Over 5 months, 20 homeless, alcohol dependent veterans will be recruited
from the waiting lists for transitional or permanent housing at the Providence VA Medical
Center. Using block randomization to stratify by current duration of abstinence (less than
7 days vs. 7 or more days) and sheltering (doubled-up/unsheltered/emergency vs. transitional
sheltered), subjects will be assigned to either injection with depot naltrexone 380 mg.
monthly or oral naltrexone 50 mg daily for 16 weeks. All will have medical visits with
medication management counseling every 4 weeks with during the treatment period. Referrals
will be made to needed services in keeping with standard practice. Research assessments at
baseline and every 4 weeks through week 24 will assess alcohol consumption through
self-report on calendar-based interviews, breathalyzer and liver enzyme testing. Primary
outcomes will be alcohol consumption and time from randomization-to-30-day-sobriety.
Secondary outcomes will include housing stability (across 5 ordered categories), emergency
department and hospital utilization, and alcohol treatment participation from administrative
data, CPRS abstracting and self-report.