Clinical trials: Opioid Withdrawal
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)
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
Opioid Use
Esophageal Dysfunction Associated With Opioids: Clinical Response and Manometric Findings After Opioid Discontinuation
Background: Opioid-induced esophageal dysfunction is characterized by altered motility of the esophageal body or impaired function of the esophageal sphincters secondary to chronic opioid use.
- Trial name
- NCT06522633
- Testing
- The intervention involves the discontinuation of the opioid.
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Hospital Clinic of Barcelona
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
Opioid Use, Opioid-Related Disorders
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and…
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose
- Trial name
- SOONER (NCT04740099)
- Testing
- SOONER Video & Kit, Standard of Care
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Opioid Withdrawal, Opioid-use Disorder
Buprenorphine in the Emergency Department
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal.
- Trial name
- BED (NCT03174067)
- Testing
- Buprenorphine, Clonidine
- Volunteers
- 26 people
- Sponsor
- St. Joseph's Health Centre Toronto
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this…
- Trial name
- NCT05937594
- Testing
- Buccal swab saliva for further genetic testing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Milton S. Hershey Medical Center
Opioid Withdrawal (Disorder)
Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid…
- Trial name
- NCT06047834
- Testing
- Standard of Care with Lofexidine, Standard of Care without Lofexidine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- BioCorRx Pharmaceuticals Inc
Neonatal Abstinence Syndrome, Substance Withdrawal, Neonatal
The Effect of Music Therapy on Newborns
The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS).
- Trial name
- NCT03987165
- Testing
- Music Therapy
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Tulane University
Respiratory Failure
Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit…
- Trial name
- NCT00142766
- Testing
- Nurse Implemented Goal-Directed Comfort Algorithm
- Where
- 3 sites in United States
- Volunteers
- 245 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)