Opioid Withdrawal (Disorder)Phase 1NCT06711640
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
A Phase 1 study testing LUCEMYRA (lofexidine) tablets in people with Opioid Withdrawal (Disorder) and Opioid Use Disorder, run by USWM, LLC (dba US WorldMeds) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- What is being tested?
- LUCEMYRA (lofexidine) tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written minor assent obtained either in English or Spanish, as applicable, in accordance with local laws and Institutional Review Board (IRB) requirements. Additionally, written informed consent obtained from the participant's parent or LAR/guardian(s) in accordance with local laws and IRB requirements.
- Participant is willing and able to comply with scheduled visits, study dosing, laboratory tests, and other study procedures.
- Participant can swallow tablets the same size as LUCEMYRA.
- Adolescent male or female participants ≥12 years and <18 years of age (at the time of study entry).
- Minimum weight ≥30 kg.
- Female participants of childbearing potential must agree to practice a medically acceptable method of contraception (e.g., intrauterine device, hormonal contraception started at least one full cycle before study enrollment or barrier method in conjunction with spermicide) for the duration of the study (including 2 months after study completion). With approval by the Investigator, participants' parents or legal guardians may select abstinence as a form of birth control if deemed more appropriate. For the purposes of this study, all females are considered of childbearing potential unless they are confirmed by the Investigator to be premenarchal, biologically sterile, or surgically sterile (e.g., hysterectomy, bilateral oophorectomy, tubal ligation).
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- 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); documentation of opioid use in the participant's medical record; or self-report of opioid use by participant and seeking treatment for OUD.
- Reported use of fentanyl, heroin, morphine, or any opioid with a half-life similar to heroin or morphine such as Vicodin®, Lortab®, Lorcet®, Percocet®, Percodan®, Tylox®, or hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected, or swallowed after chewing) for at least 21 of the past 30 days and use within 2 days of admittance to the inpatient clinic.
- Urine toxicology screen positive for opioids.
- Vital signs measured in a seated position after the participant has rested for 5 minutes must be as follows:
- Heart rate: ≥60 beats per minute
- Systolic blood pressure: ≥100 mmHg
- Diastolic blood pressure: ≥65 mmHg
Who cannot join
- Known or suspected pregnancy, planned pregnancy, or lactation.
- Treatment with an investigational drug, device, or biological agent within 30 days prior to Screening, or during LUCEMYRA administration in this study.
- Any medical illness, condition, or clinical finding that, in the opinion of the Investigator and/or the Sponsor, would put the participant at undue risk or interfere with the participant's ability to complete the study.
- Any anticipated or scheduled surgery during the study period.
- Major surgery within 30 days before Screening.
- Have clinically significant abnormal laboratory values as determined by the Investigator.
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- Abnormal cardiovascular exam at Screening, including any of the following:
- Clinically significant abnormal ECG (e.g., second or third-degree heart block, uncontrolled arrhythmia)
- QT with Fridericia's correction (QTcF) of ≥450 msec
- History of QT interval prolongation Note: if the QTcF interval meets the above criteria, the value may be confirmed by repeating the measurement (twice, if necessary). If 2 of 3 values meet the above criteria, the participant will be excluded from participation.
- Mild, moderate, or severe renal dysfunction, defined as an estimated glomerular filtration rate <90 mL/min/1.73 m2 at Screening.
- Hepatic dysfunction as defined by either of the following:
- Aspartate aminotransferase or alanine aminotransferase >2 × upper limit of normal (ULN) at Screening; or
- Child-Pugh score of ≥7.
- Metastatic cancer diagnosed within the previous year or diagnosis of any malignancy or neoplasm within 3 months prior to Screening, exclusive of basal cell carcinoma.
- History of lack of tolerance or lack of response to LUCEMYRA.
- Urine toxicology screen positive for methadone.
- Self-reported use of methadone in the 14 days prior to Screening.
- Current dependence, according to the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI KID) on any psychoactive substance (other than caffeine, nicotine, or the opioids listed in inclusion criterion #9) that requires detoxification or dose reduction as part of the pre-defined individual participant opioid withdrawal treatment goal.
- A psychiatric disorder that, in the opinion of the Investigator, requires ongoing treatment making study participation unsafe or treatment compliance difficult.
- History of suicidal behavior within the past 30 days or the participant is at risk of selfharm or harm to others as evidenced by endorsement of items 4 or 5 on the C-SSRS assessed prior to dosing on Day 1.
- Received any of the following drugs listed, within 14 days or 5 half-lives (whichever islonger) before Day -1: Amiodarone, armodafinil, buproprion, Celecoxib, Cimetidine, Cinacalet, Ciproflaxin, Diphenhydramine, Duloxetine, Enoxacin, Escitalopram, Fluoxetine, Fluvoxamine, Gefitinib, Hydroxychloroquine, Methoxsalen, Mexiletine, Moclobemide, Paroxetine, Propafenone, Quinidine, Ranitidine, Ritonavir, Sertraline, Terbinafine, Thiabendazole, Ticlopidine, Voriconazole
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
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.
Read the detailed description
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. The objectives of the study are to evaluate the PK parameters, as well as safety and tolerability. The effectiveness of LUCEMYRA on the signs and symptoms of acute opioid withdrawal will also be evaluated.
- Conditions
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- Being tested
- LUCEMYRA (lofexidine) tablets
- Keywords
- Opioid Withdrawal Syndrome, LUCEMYRA, Lofexidine Hydrochloride, Opioid Withdrawal Management, Adolescent, opioid discontinuation, opioid, medications for opioid use disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCEMYRA (lofexidine) tabletsDrug
Tablets. Participants weighing ≥45 kg: three 0.18 mg tablets (0.54 mg) four times per day (QID). Participants weighing ≥30 to <45 kg: two 0.18 mg tablets (0.36 mg) QID.
| Study group | Role | What they receive |
|---|---|---|
| LUCEMYRA: 0.54 mg | Experimental | 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. Receives: Drug: LUCEMYRA (lofexidine) tablets |
| LUCEMYRA: 0.36 mg | Experimental | 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. Receives: Drug: LUCEMYRA (lofexidine) tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak and trough plasma concentrations following daily LUCEMYRA doses during clinic confinement
Measured: Day 1 (2, 3, 4, 5, 9 hours post dose), Days 2-4 (pre-dose and 4 hours post first daily dose), Taper Days 1-4 (pre-dose and 4 hours post first daily dose), Day of Discharge
Secondary outcomes (9)
Estimation of apparent clearance and apparent volume of distribution for lofexidine and evaluation of possible covariates affecting PK
Measured: Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), discharge (1 day)
Treatment-emergent adverse events (TEAEs)
Measured: Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), safety monitoring (2.5 days), discharge (1 day), 30 day follow up
Vital signs: Heart Rate
Measured: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Vital Signs: Systolic blood pressure
Measured: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Vital Signs: Diastolic blood pressure
Measured: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Electrocardiograms (ECGs) QT Interval
Measured: Day -7 to -1, Day 3
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Day -7 to -1, Day 1, 2.5 days after last dose (discharge)
Number of participants with abnormal laboratory test results (hematology)
Safety laboratory assessments including blood tests for hematology will be performed.
Measured: Day -7 to -1, 2.5 days after last dose (discharge)
Number of participants with abnormal laboratory test results (clinical chemistry)
Safety laboratory assessments including blood tests for clinical chemistry will be performed.
Measured: Day -7 to -1, 2.5 days after last dose (discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to strategic portfolio decisions following divestiture of the investigational product.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- USWM, LLC (dba US WorldMeds)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711640
- Sponsor's protocol ID
- USWM-LX1-1014
- Other IDs
- 1UG3DA061620
- Status last verified
- Jul 2025
- First submitted
- 19 Nov 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
- ClinicalTrials.gov ID
- NCT06711640
- Acronym / sponsor ID
- USWM-LX1-1014
- Conditions
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- Keywords
- Opioid Withdrawal Syndrome, LUCEMYRA, Lofexidine Hydrochloride, Opioid Withdrawal Management, Adolescent, opioid discontinuation, opioid, medications for opioid use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment due to strategic portfolio decisions following divestiture of the investigational product.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- USWM, LLC (dba US WorldMeds)Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Dec 2024 (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.
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.
Detailed description
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. The objectives of the study are to evaluate the PK parameters, as well as safety and tolerability. The effectiveness of LUCEMYRA on the signs and symptoms of acute opioid withdrawal will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUCEMYRA: 0.54 mg | Experimental | Drug: LUCEMYRA (lofexidine) tabletsThe 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. |
| LUCEMYRA: 0.36 mg | Experimental | Drug: LUCEMYRA (lofexidine) tabletsThe 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 may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Written minor assent obtained either in English or Spanish, as applicable, in accordance with local laws and Institutional Review Board (IRB) requirements. Additionally, written informed consent obtained from the participant's parent or LAR/guardian(s) in accordance with local laws and IRB requirements.
- Participant is willing and able to comply with scheduled visits, study dosing, laboratory tests, and other study procedures.
- Participant can swallow tablets the same size as LUCEMYRA.
- Adolescent male or female participants ≥12 years and <18 years of age (at the time of study entry).
- Minimum weight ≥30 kg.
Key exclusion criteria (22 listed)
- Known or suspected pregnancy, planned pregnancy, or lactation.
- Treatment with an investigational drug, device, or biological agent within 30 days prior to Screening, or during LUCEMYRA administration in this study.
- Any medical illness, condition, or clinical finding that, in the opinion of the Investigator and/or the Sponsor, would put the participant at undue risk or interfere with the participant's ability to complete the study.
- Any anticipated or scheduled surgery during the study period.
- Major surgery within 30 days before Screening.
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 |
|---|---|---|
| LUCEMYRA (lofexidine) tabletsTablets. Participants weighing ≥45 kg: three 0.18 mg tablets (0.54 mg) four times per day (QID). Participants weighing ≥30 to <45 kg: two 0.18 mg tablets (0.36 mg) QID. | Drug | LUCEMYRA: 0.36 mg, LUCEMYRA: 0.54 mg |
Primary outcome
Peak and trough plasma concentrations following daily LUCEMYRA doses during clinic confinement
Time frame: Day 1 (2, 3, 4, 5, 9 hours post dose), Days 2-4 (pre-dose and 4 hours post first daily dose), Taper Days 1-4 (pre-dose and 4 hours post first daily dose), Day of Discharge
9 secondary outcomes
Estimation of apparent clearance and apparent volume of distribution for lofexidine and evaluation of possible covariates affecting PK
Time frame: Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), discharge (1 day)
Treatment-emergent adverse events (TEAEs)
Time frame: Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), safety monitoring (2.5 days), discharge (1 day), 30 day follow up
Vital signs: Heart Rate
Time frame: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Vital Signs: Systolic blood pressure
Time frame: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Vital Signs: Diastolic blood pressure
Time frame: Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14)
Electrocardiograms (ECGs) QT Interval
Time frame: Day -7 to -1, Day 3
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Day -7 to -1, Day 1, 2.5 days after last dose (discharge)
Number of participants with abnormal laboratory test results (hematology)
Time frame: Day -7 to -1, 2.5 days after last dose (discharge)
Number of participants with abnormal laboratory test results (clinical chemistry)
Time frame: Day -7 to -1, 2.5 days after last dose (discharge)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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 1 study testing LUCEMYRA (lofexidine) tablets in people with Opioid Withdrawal (Disorder) and Opioid Use Disorder, run by USWM, LLC (dba US WorldMeds) 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 14 inclusion and 22 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: withdrawn, as of the sponsor's last update on 1 Aug 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Peak and trough plasma concentrations following daily LUCEMYRA doses during clinic confinement (time frame: Day 1 (2, 3, 4, 5, 9 hours post dose), Days 2-4 (pre-dose and 4 hours post first daily dose), Taper Days 1-4 (pre-dose and 4 hours post first daily dose), Day of Discharge). 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 Aug 2025.