CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 286 enrolled
Drug / intervention
Lofexidinedrug
Likely dose
Lofexidine 3.2 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/NCT02363998
NCT02363998Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Safety Study of Lofexidine

USWM, LLC (dba US WorldMeds)·interventional·Posted Feb 16, 2015·Updated Mar 22, 2022

In Brief

A Phase 3 clinical trial evaluating Lofexidine for Opioid Withdrawal. Completed, enrolled 286 participants across 18 sites.

Detailed Summary

The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and buprenorphine. This study will take place in a variety of clinical scenarios, both in-clinic and outpatient settings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Withdrawal
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 16, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.4 years ago

Interventions

Lofexidinedrug

All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.