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Home › Conditions › Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Neonatal Abstinence Syndrome

19 trials tracked for Neonatal Abstinence Syndrome: 10 in phase 3 or 4 and 6 with published results. The most-cited published study has 221 citations.

19Trials tracked
10Phase 3 & 4
0Recruiting
6With published results
Phase distribution
Phase 4 5 Phase 3 5 Phase 2 3 Other / NA 6
  1. Phase 3 The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels Completed · 221 cited
  2. Phase 3 Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome Completed · 164 cited
  3. Phase 3 Improving Outcomes in Neonatal Abstinence Syndrome Completed · 101 cited
  4. Phase 4 NAS Treatment - Opiate Versus Non-Opiate Completed · 76 cited
  5. Phase 3 Fetal and Infant Effects of Maternal Buprenorphine Treatment Completed · 39 cited
  6. Phase 4 Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome Completed · 35 cited
Show 13 more trials
  1. Phase 4 Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal Completed
  2. Phase 4 Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Completed
  3. Phase 4 Treatment of Neonatal Abstinence Syndrome Completed
  4. Phase 3 Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain Completed
  5. Phase 2 Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women Completed
  6. Phase 2 Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure Completed
  7. Phase 2 Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome Completed
  8. N/A Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies Completed
  9. N/A Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome Completed
  10. N/A Weighted Blankets With Infants With NAS Completed
  11. N/A The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky Completed
  12. N/A tAN to Mitigate Withdrawal Behaviors in Neonates Completed
  13. N/A Donor Human Milk in Neonatal Abstinence Syndrome Completed

Showing the 19 most-cited and recently-updated of 19 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Neonatal Abstinence Syndrome: what the trials found

Pharmacological management for Neonatal Abstinence Syndrome (NAS) includes several agents. Morphine was evaluated in multiple trials, with studies reporting specific NNNS scores 1 and monitoring growth outcomes such as weight change, head circumference, and length at 18 months 8. Methadone was also utilized, with data showing no significant difference in the requirement for a second drug for withdrawal between groups 4.

Buprenorphine interventions showed significant impacts on clinical metrics. Sublingual buprenorphine was associated with significantly shorter lengths of treatment and hospitalization compared to alternatives (p < 0.05), as well as fewer patients requiring supplemental phenobarbital 7. Buprenorphine also demonstrated statistically significant improvements in fetal heart rate, variability, and accelerations 9.

Non-pharmacological interventions showed varying results. The use of lavender and chamomile essential oils was associated with significantly shorter lengths of hospitalization (p=0.03) and shorter durations of medication therapy (p=0.05) 6. Clonidine was evaluated in relation to changes in NNNS scores 10.

Recent results — preliminary, needs further review

  • Ondansetron showed no significant difference in the number of participants with NAS, length of hospital stay, or total dose of narcotics required (p > 0.2) 11.
  • Donor human milk was associated with a significantly higher percentage of infants achieving a GI subscore > 2 (p=0.001) 18.
  • Telemedicine programs showed varying levels of prenatal engagement and infant Apgar scores, but were not confirmed for specific NAS outcome improvements 14.
  • Stochastic Vibrotactile Stimulation (SVS) did not show significant differences in morphine dosage or length of stay 15.
  • Transcutaneous Auricular Neurostimulation (tAN) was observed with no adverse events related to bradycardia, feeding issues, or skin irritation in a small sample 16.

For the clinician treating this condition

  • Buprenorphine (specifically sublingual) is associated with significantly reduced treatment duration and hospitalization time compared to other protocols 7.
  • Buprenorphine demonstrates statistically significant improvements in fetal heart rate metrics, including variability and accelerations 9.
  • Lavender and chamomile essential oils are associated with shorter hospital stays and shorter durations of medication therapy 6.

AI synthesis of 12 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
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