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NCT01155869 · ClinicalTrials.gov registry record · Phase 4
Pilot Study of Depot NTX in Homeless Veterans
A Phase 4 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT01155869: Clinical Trial Phase 4 study, sponsored by US Department of Veterans Affairs.
NCT01155869 is a Phase 4 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01155869, a Phase 4 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Oral Naltrexone
- DRUG Depot naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
Why NCT01155869 stopped before completion
NCT01155869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral Naltrexone is the first listed.
NCT01155869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01155869 about?
NCT01155869 is a clinical study titled "Pilot Study of Depot NTX in Homeless Veterans". 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 n...
What is the current status of trial NCT01155869?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2010-08. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01155869?
The interventions under investigation include: Oral Naltrexone (DRUG), Depot naltrexone (DRUG).
Who is sponsoring clinical trial NCT01155869?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01155869's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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