Clinical trialNCT04056182CompletedPhase 2Interventional

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

SponsorNew York State Psychiatric InstituteEnrollment20Opioid-use Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

FRANCES R (MD) R LEVIN, MD
New York Psychiatric Institute
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Stars/nyspi-Columbia University
New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lofexidine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Sept 2019
Primary completion: 29 Jan 2021
Completion: 29 Jan 2021
Last update posted: 9 Dec 2021
Registered enrollment: 20
Registry id: NCT04056182

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.