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ClinicalTrials.gov 2 recruiting now official registry

Neonatal Abstinence Syndrome clinical trials

Every US clinical trial registered for Neonatal Abstinence Syndrome — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

18 US clinical trials · 2 currently recruiting

The research picture

Neonatal Abstinence Syndrome has 18 registered US clinical trials, 2 of them open to new participants right now — about 11% of the total.

2
recruiting participants now
11%
of trials open to enrollment
5
in Phase 3–4 (later-stage)
3
top sponsor: T. John Winhusen, PhD

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

RECRUITING NA 50 participants

An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)

University of Pennsylvania

NCT06576323

RECRUITING 50 participants

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Milton S. Hershey Medical Center

NCT05937594

ACTIVE NOT RECRUITING Phase 4 69 participants

Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

The Cooper Health System

NCT03092011

ACTIVE NOT RECRUITING NA 52 participants

Neurostimulation to Improve NOWS Outcomes

Spark Biomedical

NCT05129020

ACTIVE NOT RECRUITING NA 39 participants

A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

Yale University

NCT04419857

ACTIVE NOT RECRUITING NA 30 participants

Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women

Washington State University

NCT04783558

COMPLETED Phase 3 140 participants

Medication Treatment for Opioid Use Disorder in Expectant Mothers

T. John Winhusen, PhD

NCT03918850

COMPLETED Phase 3 120 participants

Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

Henrietta Bada

NCT03396588

COMPLETED 97 participants

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

T. John Winhusen, PhD

NCT03911466

COMPLETED Phase 2 85 participants

RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants

University of Pittsburgh

NCT02178189

COMPLETED Phase 2 80 participants

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

National Institute on Drug Abuse (NIDA)

NCT00510016

COMPLETED NA 74 participants

Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome

MetroHealth Medical Center

NCT03549936

COMPLETED 71 participants

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

T. John Winhusen, PhD

NCT03911739

COMPLETED Phase 1 60 participants

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Thomas Jefferson University

NCT00521248

COMPLETED 46 participants

MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

Boston Medical Center

NCT03718104

COMPLETED Phase 4 40 participants

Treatment of Neonatal Abstinence Syndrome

Eastern Maine Medical Center

NCT01723722

COMPLETED Phase 4 17 participants

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Indiana University

NCT04298853

COMPLETED Phase 1 11 participants

Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

Thomas Jefferson University

NCT01671410

Phase Distribution

PhaseTrial count
Phase 1 2
Phase 2 2
Phase 3 2
Phase 4 3

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Neonatal Abstinence Syndrome Trial Landscape

ClinicalTrials.gov lists 18 US studies indexed under Neonatal Abstinence Syndrome, and 2 of those are currently open to recruitment — roughly 11% 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 Abstinence Syndrome shows 5 late-stage studies (Phase 3 and Phase 4 combined) alongside 4 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 Abstinence Syndrome is led by T. John Winhusen, PhD with 3 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 18 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 Abstinence Syndrome?

PlainTrial tracks 18 US clinical trials for Neonatal Abstinence Syndrome, of which 2 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Neonatal Abstinence 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.

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.

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