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NCT00620750 · ClinicalTrials.gov registry record · Phase 4
Extended-release Naltrexone for Alcohol Dependence in Primary Care
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT00620750 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 72 participants.
The verdict
NCT00620750, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study Summary
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.
Interventions
- DRUG Extended release injectable naltrexone (Vivitrol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00620750
The ClinicalTrials.gov registry entry for NCT00620750 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Extended release injectable naltrexone (Vivitrol) is the first listed.
NCT00620750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00620750 about?
NCT00620750 is a clinical study titled "Extended-release Naltrexone for Alcohol Dependence in Primary Care". Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependenc...
What is the current status of trial NCT00620750?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2007-07. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00620750?
The interventions under investigation include: Extended release injectable naltrexone (Vivitrol) (DRUG).
Who is sponsoring clinical trial NCT00620750?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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