LUCEMYRA for Opioid Withdrawal Syndrome

Overseen By Kim New

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: USWM, LLC (dba US WorldMeds)

Must not be taking: Methadone, others

Disqualifiers: Pregnancy, Renal dysfunction, Hepatic dysfunction, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests LUCEMYRA, a medication designed to alleviate withdrawal symptoms when stopping opioid use. The goal is to evaluate its safety and how the body processes it in young people aged 12 to 17 who have frequently used opioids like heroin or fentanyl in the past month. Participants should be seeking treatment for opioid use disorder and must have used opioids at least 21 days in the past month. Those who have recently stopped using opioids and are experiencing withdrawal may find this study suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take certain drugs like methadone or those listed in the exclusion criteria within 14 days before the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that LUCEMYRA is likely to be safe for humans?

A previous study showed that LUCEMYRA, also known as lofexidine, is generally safe for treating opioid withdrawal. Several clinical trials have confirmed its safety. These trials included both adults and teenagers who were stopping opioid use. While LUCEMYRA can help with withdrawal symptoms, it does not completely eliminate them.

The treatment is usually well-tolerated, but like any medication, it can have side effects. Common side effects include low blood pressure, dizziness, and dry mouth. These were noted in studies and can vary from person to person. Consider these factors when deciding to participate in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LUCEMYRA for opioid withdrawal syndrome because it offers a targeted approach that differs from traditional treatments like methadone or buprenorphine, which are opioid-based. LUCEMYRA is a non-opioid medication that works by reducing the release of norepinephrine, a key driver of withdrawal symptoms, providing relief without the risk of addiction. Additionally, its dosage is tailored based on the patient's weight, ensuring a more personalized treatment. This unique mechanism and individualized dosing make LUCEMYRA an innovative option in managing withdrawal symptoms.

What evidence suggests that LUCEMYRA might be an effective treatment for opioid withdrawal syndrome?

Studies have shown that LUCEMYRA, also known as lofexidine, effectively reduces symptoms of opioid withdrawal. Research indicates that it calms the nervous system, easing withdrawal symptoms. In previous studies, patients taking lofexidine reported milder withdrawal symptoms compared to those taking a placebo. LUCEMYRA also increased the likelihood of patients staying in treatment longer. Overall, it is considered safe and well-tolerated for managing opioid withdrawal symptoms. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

History of opiate use as confirmed by diagnosis of OUD according to the diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or self-report of opioid use by participant and seeking treatment for OUD

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive LUCEMYRA for opioid withdrawal management

7 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LUCEMYRA

Trial Overview 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.

How Is the Trial Designed?

Group I: LUCEMYRA: 0.54 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

USWM, LLC (dba US WorldMeds)

Lead Sponsor

Trials

24

Recruited

1,800+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Lofexidine hydrochloride (Lucemyra) is effective in managing opioid withdrawal symptoms, providing a non-opioid treatment option for individuals undergoing detoxification.

Erenumab-aooe (Aimovig) has been shown to significantly reduce the frequency of migraine attacks, offering a targeted approach to migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical Approval Update. Choy, M.[2020]

Current treatment standards for opioid withdrawal include μ-opioid receptor agonists like methadone and partial agonists like buprenorphine, which are effective in managing withdrawal symptoms in patients with opioid use disorder.

Future research is needed to explore strategies for stabilizing patients on extended-release naltrexone and transitioning between different medications, which could improve treatment outcomes for those with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in the treatment of opioid withdrawal. Srivastava, AB., Mariani, JJ., Levin, FR.[2021]

Effective management of opioid withdrawal is essential to prevent overdose and relapse in patients with opioid use disorder (OUD), emphasizing the need for a patient-centered approach in various treatment settings.

The review highlights the importance of relieving withdrawal symptoms, engaging patients in treatment, and implementing harm reduction strategies as key components of successful opioid withdrawal management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Management of Opioid Withdrawal. Torres-Lockhart, KE., Lu, TY., Weimer, MB., et al.[2023]

A study analyzing adverse drug reactions (ADRs) related to weak opioid analgesics from 2011 to 2020 found that tramadol was the most commonly reported drug, particularly affecting young women, with gastrointestinal symptoms being the most frequent.

Serious ADRs were more commonly reported in the Pharmacovigilance database, especially for codeine, but no fatalities were observed, indicating a generally safe profile for weak opioids despite the occurrence of ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10-year French vigilances retrospective study. Caré, W., Pinel, S., Dufayet, L., et al.[2023]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

In a study involving 202 participants with severe opioid use disorder, injectable hydromorphone was found to have a better safety profile than diacetylmorphine, with fewer adverse events (AEs) and serious adverse events (SAEs) reported.

Despite both medications being administered under supervision, the diacetylmorphine group experienced higher rates of opioid overdoses, particularly in the first month of treatment, highlighting the importance of careful monitoring in opioid addiction therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder. Oviedo-Joekes, E., Brissette, S., MacDonald, S., et al.[2018]

A comprehensive analysis of 12,819,518 reports in the FDA Adverse Event Reporting System revealed that opioids like morphine and fentanyl are associated with known adverse events such as bradycardia and respiratory depression, confirming their risks during use.

The study also identified unexpected acute adverse drug reactions, including toxic leukoencephalopathy and coma, highlighting the need for ongoing safety evaluations of opioids beyond their established risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong opioids-induced cardiac, neurologic, and respiratory disorders: a real-world study from 2004 to 2023 based on FAERS. Dai, M., Dou, X., Chen, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7377538/

A Comprehensive Update of Lofexidine for the Management ... The treatment of opioid withdrawal using lofexidine is generally safe, well-tolerated, and effective. Lofexidine is used to decrease the sympathetic tone that ...

2. lucemyra.com lucemyra.com/wp-content/uploads/2025/07/BioCorRx-Pharmaceuticals-LucemyraEducational-Piece.pdf

BioCorRx-Pharmaceuticals-LucemyraEducational-Piece.pdf Withdrawal outcomes were characterized at 30 days of follow-up. N=598—lofexidine, n=166; clonidine, n=432. Lofexidine was more effective at mitigating ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6968526/

Efficacy of lofexidine for mitigating opioid withdrawal symptoms This simplified analysis confirmed previous per-protocol results, that lofexidine better reduces OWS severity and increases retention compared with placebo in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0376871617301874

A phase III, randomized, multi-center, double blind ... Lofexidine has demonstrated better efficacy than placebo for reducing opioid withdrawal symptoms in patients undergoing opioid withdrawal with less reported ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06711640

Study Details | NCT06711640 | A Pharmacokinetic, Safety, ... 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6541556/

Safety and Efficacy of Lofexidine for Medically Managed ... Data suggest that lofexidine is a generally safe and effective nonopioid treatment for opioid withdrawal. Lofexidine could serve as a withdrawal treatment ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/209229s000lbl.pdf

Lucemyra - accessdata.fda.gov The safety of LUCEMYRA was supported by 3 randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies ...

8. lucemyra.com lucemyra.com/wp-content/uploads/2025/07/BioCorRx-Pharmaceuticals-Lucemyra-CaregiverDiscGuide.pdf

A Caregiver's Guide To Opioid Withdrawal LUCEMYRA will not completely prevent the symptoms of opioid withdrawal and is not a treatment for opioid use disorder. Please see the full Important Safety ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/lofexidine-oral-route/description/drg-20443753

Lofexidine (oral route) - Side effects & dosage For opioid withdrawal symptoms: Adults—The usual dose is three 0.18 milligram (mg) tablets taken 4 times a day. Your doctor may adjust your dose as needed.