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Neonatal Opioid Withdrawal Syndrome clinical trials
Every US clinical trial registered for Neonatal Opioid Withdrawal Syndrome — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.
8 US clinical trials · 2 currently recruiting
The research picture
Neonatal Opioid Withdrawal Syndrome has 8 registered US clinical trials, 2 of them open to new participants right now — about 25% of the total.
- 2
- recruiting participants now
- 25%
- of trials open to enrollment
- 3
- in Phase 3–4 (later-stage)
- 2
- top sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.
Active & Recent Trials
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
HELP for NOWS Consortium
NCT07278375
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Milton S. Hershey Medical Center
NCT05937594
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
NCT04149509
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
NCT04214834
Neurostimulation to Improve NOWS Outcomes
Spark Biomedical
NCT05129020
Medication Treatment for Opioid Use Disorder in Expectant Mothers
T. John Winhusen, PhD
NCT03918850
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
T. John Winhusen, PhD
NCT03911466
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Indiana University
NCT04298853
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 3 | 2 |
| Phase 4 | 1 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the Neonatal Opioid Withdrawal Syndrome Trial Landscape
ClinicalTrials.gov lists 8 US studies indexed under Neonatal Opioid Withdrawal Syndrome, and 2 of those are currently open to recruitment — roughly 25% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
The phase distribution for Neonatal Opioid Withdrawal Syndrome shows 3 late-stage studies (Phase 3 and Phase 4 combined) alongside 0 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
Top sponsor activity for Neonatal Opioid Withdrawal Syndrome is led by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program with 2 indexed trials, alongside 5 other organizations in the top contributor list. The list on this page surfaces up to 8 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for Neonatal Opioid Withdrawal Syndrome?
PlainTrial tracks 8 US clinical trials for Neonatal Opioid Withdrawal Syndrome, of which 2 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for Neonatal Opioid Withdrawal Syndrome?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.