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Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Neonatal Opioid Withdrawal Clear all
Completed Phase 1 Interventional

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

NCT00521248
View directory record Official record
Conditions
Neonatal Abstinence Syndrome
Interventions
buprenorphine, Oral morphine solution
Drug
Lead sponsor
Thomas Jefferson University
Other
Eligibility
Not listed
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2010
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Not applicable Interventional

Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.

NCT04834297
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Prapela SVS mattress
Other
Lead sponsor
Tufts Medical Center
Other
Eligibility
0 Days to 2 Days
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 13, 2025 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

The Effect of Music Therapy on Newborns

NCT03987165
View directory record Official record
Conditions
Neonatal Abstinence Syndrome, Substance Withdrawal, Neonatal
Interventions
Music Therapy
Other
Lead sponsor
Tulane University
Other
Eligibility
1 Minute to 1 Month
Enrollment
42 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2024
U.S. locations
1
States / cities
Metairie, Louisiana
Source: ClinicalTrials.gov public record
Updated Aug 8, 2024 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 4 Interventional Results available

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

NCT04298853
View directory record Official record
Conditions
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Interventions
Morphine PRN, Morphine scheduled
Drug
Lead sponsor
Indiana University
Other
Eligibility
Up to 28 Days
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Oct 5, 2022 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 3 Interventional

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

NCT05980260
View directory record Official record
Conditions
Neonatal Opiate Withdrawal Syndrome
Interventions
Symptom-based Dosing Approach, Scheduled Opioid Taper Approach
Other
Lead sponsor
HELP for NOWS Consortium
Network
Eligibility
1 Hour to 48 Hours
Enrollment
626 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
23
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Wilmington, Delaware + 16 more
Source: ClinicalTrials.gov public record
Updated May 17, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 2 Interventional Results available

Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film

NCT01871285
View directory record Official record
Conditions
Pain
Interventions
Buprenorphine, Placebo film, Oxycodone, Morphine sulfate, Placebo capsule
Drug
Lead sponsor
BioDelivery Sciences International
Industry
Eligibility
18 Years to 60 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
3
States / cities
Overland Park, Kansas • Philadelphia, Pennsylvania • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Feb 26, 2017 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 3 Interventional Results available

Medication Treatment for Opioid Use Disorder in Expectant Mothers

NCT03918850
View directory record Official record
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
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
12
States / cities
Jacksonville, Florida • Boston, Massachusetts • Albuquerque, New Mexico + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 3 Interventional Results available

Improving Outcomes in Neonatal Abstinence Syndrome

NCT01958476
View directory record Official record
Conditions
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Interventions
Neonatal Morphine Solution, Methadone, Phenobarbital
Drug
Lead sponsor
Tufts Medical Center
Other
Eligibility
Not listed
Enrollment
117 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
8
States / cities
Jacksonville, Florida • Portland, Maine • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2019 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

NCT03608696
View directory record Official record
Conditions
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Interventions
Buprenorphine
Drug
Lead sponsor
Thomas Jefferson University
Other
Eligibility
Up to 4 Weeks
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 10, 2022 · Synced Jul 21, 2026, 11:31 AM EDT
Completed No phase listed Observational

Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

NCT04049799
View directory record Official record
Conditions
Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
Interventions
Medically-supervised withdrawal, Opioid agonist treatment, Comprehensive clinical care
Other · Behavioral
Lead sponsor
University of Vermont
Other
Eligibility
18 Years to 41 Years · Female only
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
4
States / cities
Asheville, North Carolina • Chapel Hill, North Carolina • Burlington, Vermont + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2024 · Synced Jul 21, 2026, 11:31 AM EDT
Active, not recruiting Phase 2 Interventional

Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

NCT06047834
View directory record Official record
Conditions
Opioid Withdrawal (Disorder)
Interventions
Standard of Care with Lofexidine, Standard of Care without Lofexidine
Drug · Other
Lead sponsor
BioCorRx Pharmaceuticals Inc
Other
Eligibility
0 Hours to 6 Days
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Huntington, West Virginia
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Not applicable Interventional

Night Respite for Postpartum Mothers With SUD

NCT05746507
View directory record Official record
Conditions
Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder, Neonatal Opioid Withdrawal
Interventions
Night Respite Care
Behavioral
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older · Female only
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
2
States / cities
Mattapan, Massachusetts • Somerville, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 15, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Active, not recruiting Phase 3 Interventional Results available

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

NCT04214834
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Morphine, Methadone
Drug
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Eligibility
36 Weeks and older
Enrollment
189 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
24
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Active, not recruiting Not applicable Interventional

Neurostimulation to Improve NOWS Outcomes

NCT05129020
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Phase 2 Interventional

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

NCT00510016
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 10, 2017 · Synced Jul 21, 2026, 11:31 AM EDT
Withdrawn Phase 3 Interventional

Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)

NCT04455802
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 21, 2023 · Synced Jul 21, 2026, 11:31 AM EDT
Terminated Phase 2 Interventional Results available

CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

NCT04104646
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
CHF6563, Morphine, CHF6563 matched placebo, Morphine matched placebo
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
Up to 7 Days
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
2
States / cities
Las Vegas, Nevada • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 2, 2023 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use

NCT06410287
View directory record Official record
Conditions
Nurse's Role, Stigma, Social, Implicit Bias
Interventions
ArtSpective
Other
Lead sponsor
University of Michigan
Other
Eligibility
18 Years and older
Enrollment
99 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
2
States / cities
Saint Cloud, Minnesota • Toledo, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Terminated Phase 2Phase 3 Interventional Results available

Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants

NCT01360450
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 12, 2017 · Synced Jul 21, 2026, 11:31 AM EDT
Active, not recruiting No phase listed Observational Accepts healthy volunteers

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

NCT04149509
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Not listed
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Eligibility
Up to 1 Month
Enrollment
300 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2026
U.S. locations
6
States / cities
Birmingham, Alabama • Washington D.C., District of Columbia • Durham, North Carolina + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 28, 2025 · Synced Jul 21, 2026, 11:31 AM EDT
Completed No phase listed Observational

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

NCT03911466
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Mar 15, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Completed Not applicable Interventional Results available

tAN to Mitigate Withdrawal Behaviors in Neonates

NCT04588519
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 27, 2022 · Synced Jul 21, 2026, 11:31 AM EDT
Recruiting No phase listed Observational

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

NCT07278375
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Not listed
Lead sponsor
HELP for NOWS Consortium
Network
Eligibility
0 Minutes and older
Enrollment
796 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
22
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Wilmington, Delaware + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 24, 2026 · Synced Jul 21, 2026, 11:31 AM EDT
Recruiting No phase listed Observational

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

NCT05937594
View directory record Official record
Conditions
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Interventions
Buccal swab saliva for further genetic testing
Genetic
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
1 Day to 5 Days
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 9, 2026 · Synced Jul 21, 2026, 11:31 AM EDT