Opioid Withdrawal (Disorder)Phase 2NCT06047834
Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
A Phase 2 study of Opioid Withdrawal (Disorder), run by BioCorRx Pharmaceuticals Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 hours to 6 days
- Conditions the study is for
- Opioid Withdrawal (Disorder)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 hours to 6 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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;
- Positive maternal urine opiate screen during pregnancy or delivery; or
- Participant urine, meconium, or cord blood or tissue testing positive for opiate metabolites.
- Symptomatic with 2 consecutive scores ≥8 on the mFNAST at sites using the mFNAST OR at least one score ≥1 on the ESC assessment and with agreement from the clinical care team at sites using the ESC approach to care. Note: The study team should use the same NOWS scoring method (i.e., mFNAST or ESC assessment) to determine the patient's eligibility as is used to assess NOWS symptoms per the local standard of care.
- Can receive medications orally.
Who cannot join
- 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.
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- 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.
- Clinically significant abnormal ECG at Screening in the judgment of the Principal Investigator, including a QTc interval >480 msec on a Screening ECG. Note: if the QTc interval meets the above criteria, the value may be confirmed by repeating the measurement twice, with each ECG obtained approximately 30-60 minutes apart, and the QTc interval confirmed by a pediatric cardiologist. If the pediatric cardiologist confirms the QTc interval is >480 msec based on two of the three ECGs, the patient will be excluded from participation. If the pediatric cardiologist confirms the QTc interval is ≤480 msec based on two of the three ECGs, the patient may be considered for study entry at the discretion of the Investigator in consultation with the pediatric cardiologist. Patients with a confirmed QTc >480 msec at Screening will be monitored per local standard of care, at least once daily, until the QTc resolves to within normal range. Patients not enrolled in the study will receive additional evaluation and care as clinically indicated.
- Have clinically significant abnormal laboratory values on laboratory tests completed for clinical reasons, including laboratory values outside the normal range as determined by the local lab that would put the patient at undue risk, as determined by the Principal Investigator, including either of the following:
- Hematocrit values of <40%
- Platelet count <100,000/μL
- Requiring sustained treatment with IV fluids or supplemental oxygen. Note: Patients with a transient need for IV fluids or supplemental oxygen may be considered for inclusion in the study at the Investigator's discretion.
- Any congenital malformations or acute medical illness, condition, or clinical finding that, in the opinion of the Principal Investigator and/or the Sponsor, would put the patient at undue risk for study participation or interfere with the patient's ability to complete the study, including concerns related to medication administration or patient survival.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
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.
- Conditions
- Opioid Withdrawal (Disorder)
- Being tested
- Standard of Care with Lofexidine, Standard of Care without Lofexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care with LofexidineDrug
Participants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care with lofexidine will be sequentially assigned to 1 of 3 dose levels: Dose 1 (32 μg/kg/day, administered as 4 μg/kg/day q3h), Dose 2 (20 μg/kg/day, administered as 5 μg/kg/day q6h), or Dose 3 (16 μg/kg/day to 24 μg/kg/day administered q6h, with the final daily dose level to be decided based on data collected in participants receiving Dose 2).
Standard of Care without LofexidineOther
Participants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care without lofexidine wilt receive non-pharmacologic measures and morphine when indicated.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | All participants will receive non pharmacologic interventions per the local standard of care (i.e. non-pharmacologic measures and morphine when indicated). Receives: Other: Standard of Care without Lofexidine |
| Dose 1 | Experimental | Drug: Lofexidine (LX2) All participants will receive standard of care and 32 µg/kg/day of Lofexidine, administered as 4 µg/kg/day every 3 hours. Lofexidine will be tapered to discontinuation. Receives: Drug: Standard of Care with Lofexidine |
| Dose 2 | Experimental | Drug: Lofexidine (LX2) All participants will receive standard of care and 20 µg/kg/day of Lofexidine, administered as 5 µg/kg/day every 3 hours. Lofexidine will be tapered to discontinuation. Receives: Drug: Standard of Care with Lofexidine |
| Dose 3 | Experimental | Drug: Lofexidine (LX2) All participants will receive standard of care and 16-24 µg/kg/day of Lofexidine, administered every 6 hours, with the final daily dose level to be decided based upon data collected in participants receiving Dose 2. Lofexidine will be tapered to discontinuation. Receives: Drug: Standard of Care with Lofexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations following single dose and repeated lofexidine administration in participants
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Secondary outcomes (6)
Single dose and steady-state maximum concentrations
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Extent of accumulation (i.e., Accumulation Ratio [AR]) with repeated dosing
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Examination of dose proportionality
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Estimation of apparent clearance
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Estimation of apparent volume of distribution
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
Measured: Day 1 through Day 7
Treatment emergent adverse events (TEAEs)
To evaluate the safety of lofexidine during administration in infants experiencing NOWS
Measured: Day 1 through 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Oct 2023
- Primary completion11 May 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Withdrawal (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCorRx Pharmaceuticals Inc
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047834
- Sponsor's protocol ID
- USWM-LX2-2001
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
- ClinicalTrials.gov ID
- NCT06047834
- Acronym / sponsor ID
- USWM-LX2-2001
- Conditions
- Opioid Withdrawal (Disorder)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- BioCorRx Pharmaceuticals IncUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 11 May 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Standard of Care without LofexidineAll participants will receive non pharmacologic interventions per the local standard of care (i.e. non-pharmacologic measures and morphine when indicated). |
| Dose 1 | Experimental | Drug: Standard of Care with LofexidineDrug: Lofexidine (LX2) All participants will receive standard of care and 32 µg/kg/day of Lofexidine, administered as 4 µg/kg/day every 3 hours. Lofexidine will be tapered to discontinuation. |
| Dose 2 | Experimental | Drug: Standard of Care with LofexidineDrug: Lofexidine (LX2) All participants will receive standard of care and 20 µg/kg/day of Lofexidine, administered as 5 µg/kg/day every 3 hours. Lofexidine will be tapered to discontinuation. |
| Dose 3 | Experimental | Drug: Standard of Care with LofexidineDrug: Lofexidine (LX2) All participants will receive standard of care and 16-24 µg/kg/day of Lofexidine, administered every 6 hours, with the final daily dose level to be decided based upon data collected in participants receiving Dose 2. Lofexidine will be tapered to discontinuation. |
Who may qualify
- Ages
- 0 hours to 6 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care with LofexidineParticipants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care with lofexidine will be sequentially assigned to 1 of 3 dose levels: Dose 1 (32 μg/kg/day, administered as 4 μg/kg/day q3h), Dose 2 (20 μg/kg/day, administered as 5 μg/kg/day q6h), or Dose 3 (16 μg/kg/day to 24 μg/kg/day administered q6h, with the final daily dose level to be decided based on data collected in participants receiving Dose 2). | Drug | Dose 1, Dose 2, Dose 3 |
| Standard of Care without LofexidineParticipants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care without lofexidine wilt receive non-pharmacologic measures and morphine when indicated. | Other | Control |
Primary outcome
Plasma concentrations following single dose and repeated lofexidine administration in participants
Time frame: Day 1 through Day 7
To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
6 secondary outcomes
Single dose and steady-state maximum concentrations
Time frame: Day 1 through Day 7
Extent of accumulation (i.e., Accumulation Ratio [AR]) with repeated dosing
Time frame: Day 1 through Day 7
Examination of dose proportionality
Time frame: Day 1 through Day 7
Estimation of apparent clearance
Time frame: Day 1 through Day 7
Estimation of apparent volume of distribution
Time frame: Day 1 through Day 7
Treatment emergent adverse events (TEAEs)
Time frame: Day 1 through 30 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Opioid Withdrawal (Disorder), run by BioCorRx Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations following single dose and repeated lofexidine administration in participants (time frame: Day 1 through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.