Pilot Study of Depot NTX in Homeless Veterans
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Depot naltrexone; Oral Naltrexone
Intervention description: Depot naltrexone 380 mg. IM monthly; Naltrexone 50 mg tablet PO daily
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: alcohol dependence; homelessness; naltrexone

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.
    

Eligibility 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.