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Alpha-2 Adrenergic Agonist

Lofexidine for Neonatal Opioid Withdrawal

Q: Is this clinical trial open to participants 45 years and older?

This clinical trial's enrollment requirements specify that the youngest age for participation is 0 Hours while the oldest accepted patient must not exceed 6 Days.

Q: Has Mid Dose Lofexidine been given the green light by the FDA?

Based on the available clinical data, our team at Power gave Mid-Dose Lofexidine a rating of 2 on their safety scale. This is because Phase 2 trials have supplied evidence for its safety but not yet for its efficacy.

Q: Might I be considered a suitable candidate for this medical experiment?

Admittance to this trial necessitates the presence of opioid withdrawal syndrome and that patients are from newborns to 6 days old. Approximately 24 persons will be accepted.

Q: Is this research trial still recruiting participants?

Per the details on clinicaltrials.gov, this investigation is actively searching for prospective participants. It was posted to the website in October 2nd of 2023 and had its last amendment done two weeks later.

Q: How many participants are currently partaking in this experiment?

Correct. Per the information hosted on clinicaltrials.gov, this research project is actively recruiting individuals to participate and was last updated on October 16th 2023. 24 participants need to be enrolled from a single site.

Phase 2

Recruiting

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

Gestational age ≥35 weeks at birth

Infants <7 days of age at the time of randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through 30 day follow-up

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of lofexidine for treating opioid withdrawal symptoms in newborns exposed to opioids before birth. It will also look at the pharmacokinetics of the medication and inform further studies in kids.

Who is the study for?

This trial is for newborns under 7 days old, born at or after 35 weeks of gestation, weighing at least 1.8 kg, who are experiencing opioid withdrawal due to their mother's opioid use during pregnancy. The baby must be able to take oral medication and show specific signs of withdrawal. Babies with certain health issues like low heart rate, seizures, low platelet count, or those already treated for withdrawal are excluded.Check my eligibility

What is being tested?

The study is testing the safety and how the body processes a drug called Lofexidine in babies going through opioid withdrawal (NOWS). It compares standard care alone versus standard care plus Lofexidine to see if it helps reduce symptoms of NOWS more effectively.See study design

What are the potential side effects?

Possible side effects from Lofexidine may include slow heart rate and low blood pressure; however, specifics will be monitored closely given that this study involves newborns with delicate health conditions.

Eligibility Criteria

Inclusion Criteria

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

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My baby was born at or after 35 weeks of pregnancy.

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My baby is less than 7 days old.

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I weighed at least 1.8 kg when I was born.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through 30 day follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through 30 day follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 30 day follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma concentrations following single dose and repeated lofexidine administration in participants

Secondary outcome measures

Estimation of apparent clearance

Estimation of apparent volume of distribution

Examination of dose proportionality

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Mid Dose LofexidineExperimental Treatment1 Intervention

Drug: Lofexidine (LX2) All participants will receive standard of care and be administered 52 µg/kg/day. The daily dose will be divided into 8 equal doses administered every 3 hours. Lofexidine will be tapered to discontinuation.

Group II: Low Dose LofexidineExperimental Treatment1 Intervention

Drug: Lofexidine (LX2) All participants will receive standard of care and be administered 32 µg/kg/day. The daily dose will be divided into 8 equal doses administered every 3 hours. Lofexidine will be tapered to discontinuation.

Group III: High Dose LofexidineExperimental Treatment1 Intervention

Drug: Lofexidine (LX2) All participants will receive standard of care and be administered 80 µg/kg/day. The daily dose will be divided into 8 equal doses administered every 3 hours. Lofexidine will be tapered to discontinuation.

Group IV: ControlPlacebo Group1 Intervention

All participants will receive non pharmacologic interventions per the local standard of care (i.e. non-pharmacologic measures and morphine when indicated).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

USWM, LLC (dba US WorldMeds)Lead Sponsor

22 Previous Clinical Trials

1,807 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,707 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to participants 45 years and older?

"This clinical trial's enrollment requirements specify that the youngest age for participation is 0 Hours while the oldest accepted patient must not exceed 6 Days."

Answered by AI

Has Mid Dose Lofexidine been given the green light by the FDA?

"Based on the available clinical data, our team at Power gave Mid-Dose Lofexidine a rating of 2 on their safety scale. This is because Phase 2 trials have supplied evidence for its safety but not yet for its efficacy."

Answered by AI

Might I be considered a suitable candidate for this medical experiment?

"Admittance to this trial necessitates the presence of opioid withdrawal syndrome and that patients are from newborns to 6 days old. Approximately 24 persons will be accepted."

Answered by AI

Is this research trial still recruiting participants?

"Per the details on clinicaltrials.gov, this investigation is actively searching for prospective participants. It was posted to the website in October 2nd of 2023 and had its last amendment done two weeks later."

Answered by AI

How many participants are currently partaking in this experiment?

"Correct. Per the information hosted on clinicaltrials.gov, this research project is actively recruiting individuals to participate and was last updated on October 16th 2023. 24 participants need to be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

2023. "Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047834.