Clinical trials: Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Opiate Withdrawal Syndrome
Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal
The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults.
- Trial name
- MTH01 (NCT01945736)
- Testing
- Methadone
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Kevin Watt
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
- Trial name
- EXPAND (NCT04666610)
- Testing
- Brivaracetam
- Where
- 35 sites in United States, Georgia and 5 more
- Volunteers
- 154 people
- Sponsor
- UCB Biopharma SRL
Drug Withdrawal Symptoms, Critical Care
Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
The study is a prospective interventional study with three main aims: 1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients. 2.
- Conditions
- Drug Withdrawal Symptoms, Critical Care, Child
- Trial name
- ASWISPIC (NCT02952846)
- Testing
- Algorithm for tapering og analgosedation
- Where
- Norway
- Volunteers
- 80 people
- Sponsor
- Oslo University Hospital
Neonatal Opiate Withdrawal Syndrome
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS.
- Trial name
- OPTimize NOW (NCT05980260)
- Testing
- Symptom-based Dosing Approach, Scheduled Opioid Taper Approach
- Where
- 23 sites in United States
- Volunteers
- 626 people
- Sponsor
- HELP for NOWS Consortium
Invasive Ventilation, Infant Pain
Dexmedetomidine for Invasive Ventilation In the NEOnate
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment
- Trial name
- NCT07493785
- Testing
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Where
- 12 sites in France
- Volunteers
- 246 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal opioid withdrawal syndrome (NOWS) can affect a newborn infant's ability to eat, sleep, and be consoled after exposure to opioids before birth.
- Conditions
- Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure, Opioid Withdrawal, Neonatal Abstinence Syndrome
- Trial name
- VOICE-NAS (NCT07864493)
- Testing
- Recorded Parent/Caregiver Voice Playback
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- University of Manitoba
Neonatal Abstinence Syndrome
How to Treat Opiate Withdrawal in Neonates
Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score.
- Trial name
- NCT02810782
- Testing
- Phenobarbital, Chlorpromazine, Morphine
- Volunteers
- 120 people
- Sponsor
- University of Zurich
HIV Infections
Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV.
- Trial name
- NCT00038259
- Testing
- Aldesleukin
- Where
- 10 sites in United States
- Volunteers
- 21 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Iatrogenic Withdrawal Syndrome
Jackson Pediatric Acupressure for Opioid Tapering
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac…
- Trial name
- NCT05025384
- Testing
- Acupressure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University Medical Center
Neonatal Abstinence Syndrome
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
- Trial name
- NAS (NCT00510016)
- Testing
- Clonidine HCL
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).
- Conditions
- Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria, Muckle-Wells Syndrome (MWS), Genetic Diseases, Inborn
- Trial name
- NCT00288704
- Testing
- rilonacept 160 mg
- Where
- 24 sites in United States
- Volunteers
- 104 people
- Sponsor
- Regeneron Pharmaceuticals
Alcohol Withdrawal Delirium, Alcohol Withdrawal
Phenobarbital for Severe Acute Alcohol Withdrawal Syndrome
Severe acute alcohol withdrawal syndrome is a potentially life-threatening condition characterized by agitation, confusion, abnormal heart rhythms and seizures.
- Conditions
- Alcohol Withdrawal Delirium, Alcohol Withdrawal, Alcohol Withdrawal Seizures
- Trial name
- PHENOMANAL (NCT03586089)
- Testing
- Phenobarbital Sodium
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- Unity Health Toronto
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-INO (NCT03911739)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- T. John Winhusen, PhD
Monocarboxylate Transporter 8 Deficiency, Allan-Herndon-Dudley Syndrome
Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency.
- Trial name
- ReTRIACt (NCT05579327)
- Testing
- Tiratricol
- Where
- 8 sites in United States, Netherlands and 1 more
- Volunteers
- 20 people
- Sponsor
- Rare Thyroid Therapeutics International AB
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Improving Outcomes in Neonatal Abstinence Syndrome
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied.
- Trial name
- NCT01958476
- Testing
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Where
- 8 sites in United States
- Volunteers
- 117 people
- Sponsor
- Tufts Medical Center
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
Neonatal Opioid Withdrawal Syndrome
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid…
- Trial name
- NCT04214834
- Testing
- Morphine, Methadone
- Where
- 24 sites in United States
- Volunteers
- 189 people
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program