CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Lofexidine 0.18 MGdrug
Likely dose
Lofexidine 0.18 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04056182
NCT04056182Phase 2Completed
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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

New York State Psychiatric Institute·interventional·Posted Aug 14, 2019·Updated Dec 9, 2021

In Brief

A Phase 2 clinical trial evaluating Lofexidine 0.18 MG for Opioid-use Disorder. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder
CountriesUnited States
CollaboratorsUSWM, LLC (dba US WorldMeds)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 14, 2019
Enrollment StartSep 1, 2019
Primary CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.9 years ago

Interventions

Lofexidine 0.18 MGdrug

Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.