NCT06711640

A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: USWM, LLC (dba US WorldMeds) · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to \<18 years old abruptly discontinuing opioid use.

Detailed description

This is a Phase 1, Open-label, PK, safety, and tolerability study of LUCEMYRA in adolescents aged ≥12 to \<18 years abruptly discontinuing opioid use. The objectives of the study are to evaluate the PK parameters, as well as safety and tolerability. The effectiveness of LUCEMYRA on the signs and symptoms of acute opioid withdrawal will also be evaluated.

Conditions

• Opioid Withdrawal (Disorder)
• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	LUCEMYRA (lofexidine) tablets	Tablets. Participants weighing ≥45 kg: three 0.18 mg tablets (0.54 mg) four times per day (QID). Participants weighing ≥30 to \<45 kg: two 0.18 mg tablets (0.36 mg) QID.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2024-12-02
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study