Clinical trials: Withdrawal Syndrome
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
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
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating…
- Trial name
- NCT02801331
- Testing
- Stochastic Vibrotactile Stimulation (SVS)
- Where
- United States
- Volunteers
- 208 people
- Sponsor
- Elisabeth B Salisbury
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 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
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
Tourette Syndrome
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
- Trial name
- NCT03530293
- Testing
- Valbenazine
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 81 people
- Sponsor
- Neurocrine Biosciences
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 Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
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 Opioid Withdrawal Syndrome
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and…
- Trial name
- OBOE (NCT04149509)
- Where
- 6 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
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
IWS Diagnosis Criteria Consensus
This is an International Delphi Consensus on the Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in adult critically ill patients. It involves the anonymous completion of a questionnaire using a 7-point Likert scale.
- Trial name
- NCT07316894
- Testing
- ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.
- Where
- Romania
- Volunteers
- 120 people
- Sponsor
- ELIAS Emergency University Hospital
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
Delirium, Withdrawal Syndrome
Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest.
- Conditions
- Delirium, Withdrawal Syndrome, Hospital Acquired Condition, Critical Illness Myopathy
- Trial name
- PICULiber8 (NCT03573479)
- Testing
- PICU Liber8 Bundle
- Where
- 2 sites in Canada
- Volunteers
- 130 people
- Sponsor
- McMaster University
Heroin Dependence, Morphine Dependence
Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.
- Conditions
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
- Trial name
- NCT00032968
- Testing
- Buprenorphine/naloxone
- Where
- 7 sites in United States
- Volunteers
- 341 people
- Sponsor
- University of California, Los Angeles
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.
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
Phelan McDermid Syndrome
Growth Hormone Treatment in Children With Phelan McDermid Syndrome
Phelan McDermid syndrome (PMS) is a rare genetic form of autism spectrum disorder (ASD) due to deletions or mutations in the SHANK3 gene.
- Trial name
- NCT04003207
- Testing
- Recombinant human Growth hormone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Swathi Sethuram