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Search Results Within Category "Addiction"
3 Study Matches
Adolescent Outcomes of Post-operative Opioid EXposure (APEX)
Isabelle Allen - Isabelle.Allen@cchmc.org
ALL
12 years to 17 years old
NCT06350409
Adolescent Inclusion Criteria
• Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis.
• Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent. Parent/Caregiver Inclusion Criteria
• Parent or legal guardian of an eligible adolescent.
• Parent or legal guardian willing and able to provide written informed consent. Adolescent Exclusion Criteria Adolescents meeting any of the following criteria will be excluded from study participation:
• Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
• Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
• Adolescents who do not have a caregiver who is willing to co-participate in the study.
• Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
• Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
• Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
• Adolescents who are currently pregnant or parenting.
• Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.
• Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively. Parent/Caregiver Exclusion Criteria Parents/Caregivers meeting any of the following criteria will be excluded from study participation:
• Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
• Parents/Caregivers that are currently incarcerated.
• Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
• Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis.
• Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent. Parent/Caregiver Inclusion Criteria
• Parent or legal guardian of an eligible adolescent.
• Parent or legal guardian willing and able to provide written informed consent. Adolescent Exclusion Criteria Adolescents meeting any of the following criteria will be excluded from study participation:
• Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
• Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
• Adolescents who do not have a caregiver who is willing to co-participate in the study.
• Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
• Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
• Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
• Adolescents who are currently pregnant or parenting.
• Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.
• Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively. Parent/Caregiver Exclusion Criteria Parents/Caregivers meeting any of the following criteria will be excluded from study participation:
• Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
• Parents/Caregivers that are currently incarcerated.
• Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
Opioid Use Disorder, Pain, Chronic
Adolescent Opioid Use, Post operative pain
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome (TreaT NOW)
Traci Beiersdorfer - Traci.Beiersdorfer@cchmc.org
ALL
Not specified
NCT07278375
Inclusion Criteria:
• Infant is ≥ 36 weeks' gestational age
• Infant had antenatal opioid exposure identified by at least one of the following:
• History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;
• Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
• Positive infant toxicology screen for opioids during the initial hospital stay.
• The infant is being assessed and managed for NOWS at an eligible study site.
• The infant is at risk for pharmacologic treatment for NOWS defined by either of the following: * At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof * At least 1 "yes" if assessed and managed with the Eat, Sleep, Console (ESC) care approach
• Infant met all inclusion criteria on or after March 25, 2024.
Exclusion Criteria:
• Infant has major congenital anomalies.
• Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
• Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
• Infant has undergone major surgical intervention prior to or at 48 hours of age.
• Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
• Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, NOWS
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
Allison Ackermann - allison.ackermann@cchmc.org
ALL
NCT06017622
Inclusion Criteria:
•
Inclusion Criteria:
The patient is younger than 18 years old.
• The patient visits the ED with signs and symptoms of suspected acute cannabis-induced CNS depression, as evidenced by the patient suffering from clinically significant CNS depression combined with the following criteria: a) Exposure to cannabis or cannabis-derived products, or other products containing any CB1 agonist (such as Δ8-THC, HHC) within the last 12 hours, confirmed through one or more of the following: i. Positive toxicology testing, or ii. Other clinical evidence, such as reliable collateral history (e.g., from caregivers, EMS personnel, or witnesses), physical evidence (e.g., product packaging), or a consistent self-report. AND EITHER b) Symptoms are associated with cannabis exposure and developed during, or shortly after, cannabis exposure; OR c) In the judgment of investigator or designated clinician, the presentation includes symptoms consistent with acute cannabis-induced CNS depression (e.g. respiratory rate depression, increased sedative effects).
• Blood samples are taken as part of routine clinical procedures, or the patient has an IV line through which blood can be taken.
• The LAR is willing and able to provide consent.
• The patient is willing and able to provide assent, if applicable and feasible, based on age and clinical condition. Exclusion criteria A potential patient who meets any of the following criteria will be excluded from participation in this study:
• Anything that, in the opinion of the PI, would place the patient at increased risk or preclude the patient's compliance with or completion of the study.
• Patient is presenting with signs or symptoms that are better explained by another medical condition or mental disorder, exposure to a drug other than cannabis, and, at the PI's discretion, are not induced by acute cannabis exposure.
• Patient presenting with cannabis use disorder (CUD), cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS)
• Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
Acute Cannabis-induced CNS Depression