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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 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 20 participants.

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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.

Interventions

  • DRUG Lofexidine 0.18 MG

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-09-01
Est. Completion 2021-01-29
Phase Phase 2

What the Registry Record Tells You About NCT04056182

The ClinicalTrials.gov registry entry for NCT04056182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lofexidine 0.18 MG is the first listed.

NCT04056182 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.