Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women

PHASE2CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

September 9, 2014

Primary Completion Date

September 3, 2020

Study Completion Date

September 16, 2020

Conditions
Narcotic AddictionNeonatal Abstinence Syndrome
Interventions
DRUG

Ondansetron

Pregnant women may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. 50% of the 90 mother/baby pairs will receive ondansetron; the baby will always get the same study medication as the mother.

DRUG

Placebo

All doses of placebo, whether IV or oral, will mimic the same volume as the ondansetron group to maintain the blind. Pregnant women may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. 50% of the 90 mother/baby pairs will receive placebo; the baby will always receive the same study medication as the mother.

Trial Locations (8)

19107

Thomas Jefferson University Hospital, Philadelphia

21224

Johns Hopkins Bayview Medical Center, Baltimore

38163

University of Tennessee Health Science Center, Memphis

40292

University of Louisville, Louisville

84112

The University of Utah, Salt Lake City

94110

UCSF, San Francisco General Hospital, San Francisco

94305

Stanford University Medical Center, Stanford

95128

Santa Clara Valley Medical Center, San Jose

All Listed Sponsors
collaborator

Santa Clara Valley Medical Center

OTHER

collaborator

Thomas Jefferson University

OTHER

lead

Stanford University

OTHER

NCT01965704 - Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women | Biotech Hunter | Biotech Hunter