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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Active, not recruiting Not applicable Interventional

Neurostimulation to Improve NOWS Outcomes

NCT05129020
Conditions
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Interventions
Sparrow Fledging Therapy System, Sham Sparrow Fledging Therapy System
Device
Lead sponsor
Spark Biomedical, Inc.
Industry
Eligibility
33 Weeks to 1 Year
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
3
States / cities
Charleston, South Carolina • Dallas, Texas • San Antonio, Texas
Completed Not applicable Interventional Results available

Weighted Blankets With Infants With NAS

NCT03113656
Conditions
Neonatal Abstinence Syndrome
Interventions
Weighted Blanket, Non-Weighted Blanket
Other
Lead sponsor
TriHealth Inc.
Other
Eligibility
37 Weeks and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Cincinnati, Ohio
Conditions
Neonatal Abstinence Syndrome
Interventions
High-calorie formula
Dietary Supplement
Lead sponsor
Yale University
Other
Eligibility
Not listed
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Conditions
Neonatal Abstinence Syndrome
Interventions
Structured psychosocial intervention
Behavioral
Lead sponsor
Dr. Henry Akinbi
Other
Eligibility
Female only
Enrollment
113 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
1
States / cities
Cincinnati, Ohio
Completed Phase 2Phase 3 Interventional Results available

Fetal and Infant Effects of Maternal Buprenorphine Treatment

NCT01561079
Conditions
Neonatal Abstinence Syndrome
Interventions
Buprenorphine
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 40 Years · Female only
Enrollment
127 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
2
States / cities
Baltimore, Maryland
Conditions
Neonatal Abstinence Syndrome
Interventions
Human Milk, Standard of Care
Other
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
Up to 48 Hours
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
2
States / cities
San Antonio, Texas
Conditions
Neonatal Abstinence Syndrome
Interventions
Clonidine HCL
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
Up to 14 Days
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2005
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Drug; Withdrawal Symptoms, Neonatal, Withdrawal, Fetus and Newborn Affected by Other Maternal Medication
Interventions
BZDs + opiate exposure treated with BPN, Opiates exposure treated with BPN
Drug
Lead sponsor
Gauda, Estelle B., M.D.
Individual
Eligibility
Up to 7 Days
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2014
U.S. locations
1
States / cities
St. Petersburg, Florida
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Buprenorphine or Placebo, Morphine or Placebo
Drug
Lead sponsor
Women and Infants Hospital of Rhode Island
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Providence, Rhode Island
Conditions
Neonatal Abstinence Syndrome
Interventions
Phenobarbital, Clonidine
Drug
Lead sponsor
University of Tennessee Medical Center
Other
Eligibility
35 Weeks and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Knoxville, Tennessee
Conditions
Neonatal Abstinence Syndrome
Interventions
Morphine, Methadone
Drug
Lead sponsor
University of New Mexico
Other
Eligibility
0 Hours to 12 Hours
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Albuquerque, New Mexico
Conditions
Drug Addiction
Interventions
RBT, usual care
Behavioral
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 50 Years · Female only
Enrollment
128 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2009
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
NAS
Interventions
Song of Kin, Gato box, Ocean disc, Contingent singing, Tonal Vocal holding, Muted shaker
Behavioral · Other
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
28 Weeks and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
6
States / cities
New Orleans, Louisiana • Hackensack, New Jersey • New Hyde Park, New York + 3 more
Conditions
Neonatal Abstinence Syndrome
Interventions
High Calorie Infant formula, Standard Calorie Infant Formula
Other
Lead sponsor
University of Pittsburgh
Other
Eligibility
1 Day to 3 Days
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Terminated Phase 2Phase 3 Interventional Results available

Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants

NCT01360450
Conditions
Neonatal Abstinence Syndrome
Interventions
Clonidine HCL, saline
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
5 Days to 90 Days
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Neonatal Abstinence Syndrome
Interventions
Low lactose or regular formula
Other
Lead sponsor
MetroHealth Medical Center
Other
Eligibility
1 Minute to 7 Days
Enrollment
74 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2018
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Neonatal Abstinence Syndrome
Interventions
Telemedicine, Group Care
Behavioral
Lead sponsor
Wendy F Hansen
Other
Eligibility
18 Years to 55 Years · Female only
Enrollment
269 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
11
States / cities
Ashland, Kentucky • Bowling Green, Kentucky • Corbin, Kentucky + 7 more
Conditions
Neonatal Abstinence Syndrome
Interventions
Clonidine, Placebo
Drug
Lead sponsor
Hennepin County Medical Center, Minneapolis
Other
Eligibility
36 Weeks to 45 Weeks
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018
U.S. locations
1
States / cities
Minneapolis, Minnesota
Conditions
Narcotic Addiction, Neonatal Abstinence Syndrome
Interventions
Ondansetron, Placebo
Drug
Lead sponsor
Stanford University
Other
Eligibility
Up to 45 Years
Enrollment
196 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
8
States / cities
San Francisco, California • San Jose, California • Stanford, California + 5 more
Conditions
Neonatal Abstinence Syndrome
Interventions
Stochastic Vibrotactile Stimulation (SVS)
Device
Lead sponsor
Elisabeth B Salisbury
Other
Eligibility
1 Hour to 18 Months
Enrollment
208 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Conditions
Neonatal Abstinence Syndrome
Interventions
NeoMonki
Other
Lead sponsor
Rekovar Inc.
Industry
Eligibility
Up to 4 Weeks
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2026
U.S. locations
1
States / cities
Albuquerque, New Mexico
Conditions
Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Drug Abuse in Pregnancy
Interventions
Buprenorphine Injection, Buprenorphine Sublingual Product
Drug
Lead sponsor
T. John Winhusen, PhD
Other
Eligibility
18 Years to 41 Years · Female only
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
12
States / cities
Jacksonville, Florida • Boston, Massachusetts • Albuquerque, New Mexico + 8 more
Completed Not applicable Interventional Results available

tAN to Mitigate Withdrawal Behaviors in Neonates

NCT04588519
Conditions
Neonatal Abstinence Syndrome
Interventions
Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
Device
Lead sponsor
Spark Biomedical, Inc.
Industry
Eligibility
33 Weeks to 1 Year
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
Charleston, South Carolina
Conditions
Neonatal Abstinence Syndrome
Interventions
oral morphine, sublingual buprenorphine
Drug
Lead sponsor
Thomas Jefferson University
Other
Eligibility
Not listed
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Philadelphia, Pennsylvania