LUCEMYRA for Opioid Withdrawal Syndrome

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: USWM, LLC (dba US WorldMeds)

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adolescents aged 12 to under 18 who are experiencing opioid withdrawal after stopping opioid use. The study aims to understand how the body processes LUCEMYRA in this age group and assess its safety.

Inclusion Criteria

Participant can swallow tablets the same size as LUCEMYRA

All female participants, regardless of childbearing potential, must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Screening and prior to dosing on Day 1

Vital signs measured in a seated position after the participant has rested for 5 minutes must meet specific criteria

+8 more

Exclusion Criteria

Known or suspected pregnancy, planned pregnancy, or lactation

I have not used any experimental drugs or devices in the last 30 days.

I have not had major surgery in the last 30 days.

+14 more

Participant Groups

The focus of the trial is on LUCEMYRA tablets, which are being studied for their effects on managing symptoms of opioid withdrawal in adolescents. It will look at how the drug moves through and affects young bodies.

2Treatment groups

Experimental Treatment

Group I: LUCEMYRA: 0.54 mgExperimental Treatment1 Intervention

The initial LUCEMYRA dose for this study will be based on weight. Participants who weigh ≥45 kg will receive three 0.18 mg tablets (0.54 mg) QID.

Group II: LUCEMYRA: 0.36 mgExperimental Treatment1 Intervention

The initial LUCEMYRA dose for this study will be based on weight. Participants who weigh ≥30 to \<45 kg will receive two 0.18 mg tablets (0.36 mg) QID.