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

16 Participants Needed

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.

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.

What data supports the effectiveness of the drug LUCEMYRA for treating opioid withdrawal syndrome?

LUCEMYRA works similarly to clonidine and lofexidine, which are known to help with opioid withdrawal by calming the nervous system. This suggests that LUCEMYRA might also be effective in reducing withdrawal symptoms. ^{1 2 3 4 5}

Is LUCEMYRA safe for treating opioid withdrawal syndrome?

LUCEMYRA (also known as lofexidine) has been studied for its safety in humans, and while it is generally considered safe, like any medication, it can have side effects. Common side effects include low blood pressure, slow heart rate, and dizziness, but these are usually manageable with medical supervision. ^{6 7 8 9 10}

How does the drug LUCEMYRA differ from other treatments for opioid withdrawal?

LUCEMYRA (lofexidine hydrochloride) is unique because it is an α2-adrenergic receptor agonist, which helps reduce the symptoms of opioid withdrawal without being an opioid itself, unlike other treatments like methadone or buprenorphine that are opioid-based. ^{3 11 12 13 14}

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Opioid Withdrawal Presenting as Delirium and Role of Buprenorphine: A Case Series. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Initiating buprenorphine to treat opioid use disorder without prerequisite withdrawal: a systematic review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

New directions in the treatment of opioid withdrawal. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical Management of Opioid Withdrawal. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of opioid and alcohol withdrawal in a cohort of emergency department patients. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Variation in adverse drug events of opioids in the United States. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Strong opioids-induced cardiac, neurologic, and respiratory disorders: a real-world study from 2004 to 2023 based on FAERS. [2023]

9. England 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Dexamethasone inhibition of acute opioid physical dependence in vitro is reverted by anti-lipocortin-1 and mimicked by anti-type II extracellular PLA2 antibodies. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical Approval Update. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Opioid withdrawal syndrome on switching from hydromorphone to alfentanil. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Depression of home cage wheel running is an objective measure of spontaneous morphine withdrawal in rats with and without persistent pain. [2018]