A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects

Inclusion criteria

• ✓. 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).
• ✓. 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.