Status:
TERMINATED
Pilot Study of Depot NTX in Homeless Veterans
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief 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 sobriet...
Detailed Description
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 vete...
Eligibility Criteria
Inclusion
- 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).
- Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.
- Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.
- Age between 18 and 64 years.
- Eligible to receive VA services.
- Willing to provide informed consent that will include all study procedures.
- 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).
- If female of childbearing potential -- must be using adequate contraception.
- 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.
- Speak English sufficiently to understand instructions and assessments.
Exclusion
- 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).
- Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.
- Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.
- 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.
- Stated plan to leave the area within 6 months of enrollment.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01155869
Start Date
August 1 2010
End Date
June 1 2012
Last Update
July 17 2014
Active Locations (1)
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1
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908-4799