NCT02363998

Open-Label, Safety Study of Lofexidine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: USWM, LLC (dba US WorldMeds) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects (person seeking treatment for partial or total opioid withdrawal) enrolled in this study are required to take lofexidine for a minimum of 7 days.

Conditions

• Opioid Withdrawal

Interventions

Type	Name	Description
DRUG	Lofexidine	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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-02-16
• Last updated: 2022-03-22
• Results posted: 2021-04-26

Locations

18 sites across 1 country: United States