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Alpha-2 Adrenergic Agonist

LUCEMYRA for Opioid Withdrawal Syndrome

Phase 1

Waitlist Available

Research Sponsored by USWM, LLC (dba US WorldMeds)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescent male or female participants ≥12 years and <18 years of age (at the time of study entry)

Minimum weight ≥30 kg

Must not have

Major surgery within 30 days before Screening

Any anticipated or scheduled surgery during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -7 to -1, 2.5 days after last dose (discharge)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how a medication called LUCEMYRA affects teenagers aged 12 to 18 who are stopping opioid use suddenly. The study will look at how the drug is processed in the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from taking LUCEMYRA may include low blood pressure, slow heart rate, dizziness, sleepiness, dry mouth, and potentially other reactions that can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I weigh at least 30 kg.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have surgery planned during the study period.

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My kidneys are not working properly.

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My liver is not functioning properly.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -7 to -1, 2.5 days after last dose (discharge)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -7 to -1, 2.5 days after last dose (discharge)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -7 to -1, 2.5 days after last dose (discharge) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of participants with abnormal laboratory test results (clinical chemistry)

Number of participants with abnormal laboratory test results (hematology)

Side effects data

From 2021 Phase 1 trial • 16 Patients • NCT04188730

27%

Blood pressure decreased

20%

Somnolence

13%

Decreased appetite

Abdominal pain upper

Pain

Abdominal pain

Nausea

Alanine aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Treatment C: Lofexidine Granules - Fed Conditions

Treatment A: Lofexidine Granules - Fasted Conditions

Treatment B: LUCEMYRA Tablets - Fasted Conditions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUCEMYRA (lofexidine) tablets

2021

Completed Phase 1

~20

0 / 8Eligibility criteria met