Condition (MeSH)
Neonatal Abstinence Syndrome
ClinicalTrials.gov lists 68 trials for Neonatal Abstinence Syndrome or a narrower condition beneath it. Spark Biomedical, Inc. has the most among industry and government lead sponsors, with 2.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials per phase (log scale)
68 of the 68 trials are tagged with Neonatal Abstinence Syndrome itself; the rest are tagged with a narrower condition beneath it.
When did Neonatal Abstinence Syndrome trials start? (22)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 9
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2024 | 3 |
| 2023 | 1 |
| 2022 | 1 |
| 2021 | 2 |
| 2020 | 9 |
| 2019 | 7 |
| 2018 | 7 |
| 2017 | 6 |
| 2016 | 4 |
Showing 10 of 22 earlier years.
No forecast is made for this condition: it averages 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Neonatal Abstinence Syndrome trials in? (8)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 2 |
| Phase 1/2 | 1 |
| Phase 2 | 7 |
| Phase 2/3 | 4 |
| Phase 3 | 7 |
| Phase 4 | 7 |
| Not applicable | 25 |
| Observational | 15 |
How many Neonatal Abstinence Syndrome trials are recruiting? (8)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 1 |
| Recruiting | 4 |
| Enrolling by invitation | 1 |
| Active, not recruiting | 3 |
| Completed | 49 |
Showing 5 of 8 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Neonatal Abstinence Syndrome trials? (1)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Spark Biomedical, Inc. | 2 |
Which drugs are being tested for Neonatal Abstinence Syndrome? (3)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| Buprenorphine | 7 |
| Methadone | 6 |
| Phenobarbital | 4 |
Interventions as named in the registry (12)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| PO Morphine | 11 |
| Clonidin | 8 |
| Buprenorphine Sublingual Product | 3 |
| Sublingual Buprenorphine | 2 |
| Lavender and Chamomile Essential Oils | 1 |
Showing 5 of 12 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Neonatal Abstinence Syndrome trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Preterm labor | 10 | 1 |
| Medication Administration Error | 7 | 1 |
| Non-reactive NST/Elevated dopplers | 7 | 1 |
| Sustained tachycardia | 7 | 1 |
| Pre-Eclampsia | 6 | 1 |
Showing 5 of 10 adverse events.
Which publications cover Neonatal Abstinence Syndrome? (127)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Pharmacokinetic Modeling and Model-Based Hypothesis Generation for Dose Optimization of Clonidine in Neonates With Neonatal Opioid Withdrawal Syndrome. | Clinical pharmacology and therapeutics | 2025 | Yes |
| Neurobehavioral Profiles in Opioid-Exposed and Unexposed Neonates. | The Journal of pediatrics | 2025 | Yes |
| Optimizing pharmacologic treatment for neonatal opioid withdrawal syndrome (OPTimize NOW): a symptom-based dosing approach study protocol for a multi-center, cluster crossover design randomized controlled trial. | Trials | 2025 | Yes |
| Impaired vision in children prenatally exposed to methadone: an observational cohort study. | Eye (London, England) | 2024 | Yes |
| Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial. | JAMA pediatrics | 2024 | Yes |
Showing 5 of 127 publications.
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.