Clinical trials: Substance Withdrawal Syndrome
Cystic Fibrosis, Drug Withdrawal
Qualitative Understanding of Experiences With the SIMPLIFY Trial
This qualitative longitudinal study is designed to elicit and thematically analyze the perspectives of SIMPLIFY subjects about treatment withdrawal research and treatment burden in the context of triple combination CFTR (Cystic…
- Trial name
- QUEST (NCT04320381)
- Testing
- Qualitative Interview
- Where
- 2 sites in United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Substance Withdrawal Syndrome
Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool
The purpose of this study is to assess the validity and reliability of an abstinence syndrome assessment tool used in pediatric patients with iatrogenic opioid dependence.
- Trial name
- NCT00792415
- Where
- United States
- Sponsor
- Banner Health
Neonatal Opioid Withdrawal Syndrome
Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS).
- Trial name
- NCT04834297
- Testing
- Prapela SVS mattress
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Tufts Medical Center
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
- Trial name
- NCT04298853
- Testing
- Morphine PRN, Morphine scheduled
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
Opiate Withdrawal Syndrome
Neurostimulation for Opiate Withdrawal in the PICU
This is a prospective pilot study to investigate the effects of Percutaneous Electrical Nerve Field Stimulation (PENFS) on symptoms of opioid withdrawal in pediatric patients in the intensive care unit.
- Trial name
- NOW (NCT03975192)
- Testing
- Percutaneous Electrical Nerve Field Stimulation
- Where
- United States
- Sponsor
- Medical College of Wisconsin
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
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
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)
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
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
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
Drug; Withdrawal Symptoms, Neonatal, Withdrawal
Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study
Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic treatment; those infants born to mothers with…
- Conditions
- Drug; Withdrawal Symptoms, Neonatal, Withdrawal, Fetus and Newborn Affected by Other Maternal Medication
- Trial name
- NCT02249026
- Testing
- BZDs + opiate exposure treated with BPN, Opiates exposure treated with BPN
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Gauda, Estelle B., M.D.