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NCT04056182 · ClinicalTrials.gov registry record · Phase 2
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04056182: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT04056182 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04056182, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids.
Primary Outcome
number of participants inducted onto Vivitrol
Interventions
- DRUG Lofexidine 0.18 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2021-01-29 |
| Phase | Phase 2 |
What the finished NCT04056182 record still lists
NCT04056182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Lofexidine 0.18 MG is the first listed.
NCT04056182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04056182 about?
NCT04056182 is a clinical study titled "Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment". This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection...
What is the current status of trial NCT04056182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-09-01. Estimated completion is 2021-01-29.
What interventions are being tested in trial NCT04056182?
The interventions under investigation include: Lofexidine 0.18 MG (DRUG).
Who is sponsoring clinical trial NCT04056182?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04056182's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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