Pilot Study of Depot NTX in Homeless Veterans

NCT01155869 | Terminated Phase 4 Results

• 1 other identifier: PPO 10-079
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; homelessness; naltrexone

Outcome Measures

Primary Outcomes (1)

• Mean Weekly Self-reported Alcohol Consumption

  Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.

  24 weeks

Secondary Outcomes (1)

• Treatment Participation

  16 weeks

Study Arms (2)

XR-NTX

EXPERIMENTAL

Depot naltrexone (Vivitrol) 380 mg. IM monthly

Drug: Depot naltrexone

Oral Naltrexone

ACTIVE COMPARATOR

Naltrexone 50 mg tablet PO daily

Drug: Oral Naltrexone

Interventions

Depot naltrexone DRUG

Depot naltrexone 380 mg. IM monthly

Also known as: Vivitrol

XR-NTX

Oral Naltrexone DRUG

Naltrexone 50 mg tablet PO daily

Also known as: Revia

Oral Naltrexone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Providence

Providence, Rhode Island, 02908-4799, United States

Location

Related Publications (1)

• Friedmann PD, Mello D, Lonergan S, Bourgault C, O'Toole TP. Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients. Subst Abus. 2013;34(2):94-6. doi: 10.1080/08897077.2012.763083.

  PMID: 23577900 RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Only 15 of 215 alcohol-dependent, homeless veterans would consider a study that included an intramuscular injection of XR-NTX. Of 3 given XR-NTX, only 1 returned for injection #2. Aversion to injection likely contributed to poor acceptability.

Results Point of Contact

• Title: Peter Friedmann
• Organization: Providence VA Medical Center

peter.friedmann@va.gov

401-273-7100

Study Officials

• Peter D Friedmann, MD MPH

  VA Medical Center, Providence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 2, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-06

Locations

US (1)