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Neonatal Abstinence Syndrome clinical trials

The registry lists 68 studies for Neonatal Abstinence Syndrome across 4 countries. 6 are recruiting or about to start. 55 of them are mainly about Neonatal Abstinence Syndrome (how this is decided). Per ClinicalTrials.gov, last updated 2026-10-29.

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Status

Completed
49
Terminated
6
Recruiting
4
Status unknown
3
Active, not recruiting
3
Not yet recruiting
1

Phase

Phase 2
12
Phase 3
11
Phase 4
7
Phase 1
3

Where

United States
59
France
3
Canada
2
United Kingdom
1

Who runs them

Johns Hopkins University (6) · Thomas Jefferson University (4) · University Hospital, Caen (3) · T. John Winhusen, PhD (3) · Boston Medical Center (2) · Eastern Maine Medical Center (2) · Spark Biomedical, Inc. (2) · University of South Florida (2)

What is being tested here

Drugs under test in Neonatal Abstinence Syndrome studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted

DrugOpenPhase 3All
Clonidine028
Buprenorphine037
Morphine026
Methadone015
Phenobarbital012
Ondansetron001
Opium001

Drug classes tested here Opioids 15

Coming up

0phase 3 studies under way
6studies finish main data collection within a year

Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.

All 6

Who these studies take

Of the 4 Neonatal Abstinence Syndrome studies recruiting now, 3 (75%) set no upper age limit and 1 (25%) stop at 75 or younger. 3 (75%) take children under 18. 1 (25%) are for women only and 0 (0%) for men only; 1 (25%) take healthy volunteers.

Recruiting studies that take each age, of 4
AgeWomenMen
102 (50%)1 (25%)
183 (75%)2 (50%)
303 (75%)2 (50%)
403 (75%)2 (50%)
503 (75%)2 (50%)
653 (75%)2 (50%)
753 (75%)2 (50%)
853 (75%)2 (50%)

Across all 68 studies, recruiting or not: 74% stop at 75 or younger and 74% at 65; 79% take children; 22% are for women only and 0% for men only; 15% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.

How long Neonatal Abstinence Syndrome studies take

Of 18 interventional studies with no phase under Neonatal Abstinence Syndrome, half reached primary completion within 47 months of starting, counting those still running.

Start to primary completionEvery sponsorIndustryNon-industry
Interventional, no phase47 mo30–60 · 18 studies——

Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out

Studies

Recruiting first, then most recently updated. Showing 50 of 68. Browse all 68 → or search them.