Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Du… (NCT06047834) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
United States24 participantsStarted 2023-10-02
Plain-language summary
A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid withdrawal symptoms in neonates due to intrauterine exposure to opioids, described as neonatal opioid withdrawal syndrome (NOWS) or neonatal abstinence syndrome (NAS).
This study has been designed to assess the pharmacokinetics (PK) and safety of the lofexidine in neonates experiencing NOWS. The effectiveness of lofexidine on the severity of NOWS will also be evaluated. Results from this study will be used to support dosing recommendations in neonates and to inform further studies in the pediatric patient population.
Who can participate
Age range
0 Hours – 6 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent obtained from the patient's parent or legally authorized representative(s) (LAR)/guardian(s) in accordance with local laws and Institutional Review Board (IRB) requirements.
. Infants \<7 days of age at the time of randomization.
. Gestational age ≥35 weeks at birth.
. Minimum weight ≥1.8 kg at birth.
. Infant's mother is ≥18 years of age.
. Intrauterine opiate exposure expected to contribute to NOWS symptoms, as determined by the Principal Investigator and supported by at least one of the following:
. Maternal history of opiate use during pregnancy as confirmed by diagnosis of opioid use disorder (OUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), treatment for OUD, treatment with an opioid prescribed by a licensed physician or health care worker, documentation of opiate use in maternal medical record, and/or maternal self-reported opiate use;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma concentrations following single dose and repeated lofexidine administration in participants
. Positive maternal urine opiate screen during pregnancy or delivery; or
Exclusion criteria
. Patients who developed NOWS due to prolonged neonatal intensive care unit (NICU) analgesia and sedation therapy.
. Received treatment for NOWS, including morphine, methadone, buprenorphine, clonidine, or phenobarbital before screening/randomization.
. Prenatal exposure to an investigational drug, device, or biological agent other than investigational formulations of buprenorphine or methadone administered as part of treatment for maternal opioid dependence.
. Any anticipated or scheduled surgery during the patient's inpatient treatment for NOWS through approximately 30 days after completion of their treatment for NOWS (not including circumcision).
. Seizures, confirmed by EEG.
. mFNAST score ≥14.
. Two consecutive blood pressure measurements greater than 15 minutes apart with a systolic blood pressure \<55 mm Hg.
. Two consecutive heart rate measurements \<110 bpm more than 15 minutes apart.