LUCEMYRA for Opioid Withdrawal Syndrome

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

I am between 12 and 17 years old.

I weigh at least 30 kg.

I have used certain painkillers for most of the last month and within 2 days before coming to the clinic.

Exclusion Criteria

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

I have surgery planned during the study period.

My kidneys are not working properly.

My liver is not functioning properly.

I have had a bad reaction or no response to LUCEMYRA.

Treatment Details

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.