Pilot Study of Depot NTX in Homeless Veterans

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

1. Homeless per the federal definition (HEARTH Act, 2009), which includes individuals who lack a fixed, regular, and adequate nighttime residence; and those who have a primary nighttime residence that is a supervised publicly or privately operated shelter designed to provide temporary accommodations (including welfare hotels, congregate shelters, and transitional housing); an institution that provides a temporary residence for individuals intended to be institutionalized; and/or a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings (including doubled up with a friend or family member).

2. Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.

3. Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.

4. Age between 18 and 64 years.

5. Eligible to receive VA services.

6. Willing to provide informed consent that will include all study procedures.

7. Those who report any opiate use in the past month must pass a naloxone challenge test (no sign of opiate withdrawal after IM injection of 0.8 mg naloxone).

8. If female of childbearing potential -- must be using adequate contraception.

9. Cognitively intact and showing no signs of delusional thought processes on the Short Blessed test (Callahan, 2002) and SCID checklist. Those with an untreated SMI and/or not capable of understanding the study due to an active cognitive impairment or delusional thought process will be excluded.

10. Speak English sufficiently to understand instructions and assessments.

Exclusion Criteria:

1. Untreated disorder that might make participation hazardous (e.g. untreated psychosis or bipolar disorder with mania on SCID checklist or significant suicide risk on Modified Scale of Suicidal Ideation (MSSI).

2. Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.

3. Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.

4. Contraindicated medical conditions including pregnancy/lactation; liver failure or liver function test levels greater than three times normal; glaucoma; prior adverse reaction to naltrexone; life expectancy of less than 6 months or medical condition that will likely require skilled nursing facility care) within 6 months.

5. Stated plan to leave the area within 6 months of enrollment.