Clinical trials: Neonatal Opioid Withdrawal Syndrome
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 Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Cerebral Physiology of NOWS
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Trial name
- NIRS for NOWS (NCT07610746)
- Testing
- FD-NIRS and DCS
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Indiana University
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-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and…
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs (NCT03918850)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 140 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.
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments 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-CMA (NCT03911466)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 97 people
- Sponsor
- T. John Winhusen, PhD
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
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS).
- Trial name
- TreaT NOW (NCT07278375)
- Where
- 22 sites in United States
- Volunteers
- 796 people
- Sponsor
- HELP for NOWS Consortium
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
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
- 120 people
- Sponsor
- Tufts Medical Center
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
Opioid-use Disorder, Opioid Withdrawal
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and…
- Conditions
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
- Trial name
- MOTHER DYAD (NCT04049799)
- Testing
- Medically-supervised withdrawal, Opioid agonist treatment, Comprehensive clinical care
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of Vermont
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 Opioid Withdrawal Syndrome
Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the…
- Trial name
- NCT04455802
- Where
- United States
- Sponsor
- Women and Infants Hospital of Rhode Island
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
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