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Clinical trial

Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

ID
Name
14-3053
Description
The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.
Trial arms
Trial start
2016-05-01
Estimated PCD
2023-03-01
Trial end
2023-03-01
Status
Completed
Phase
Early phase I
Treatment
Syntocinon treatment
24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).
Arms:
Syntocinon treatment
Other names:
Nasal Oxytocin treatment
Placebo
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Arms:
Placebo
Size
31
Primary endpoint
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
2 weeks
Eligibility criteria
Inclusion Criteria: * 3-6 months postpartum at start of testing * Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology) * Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk) * Healthy singleton pregnancy * English fluency that will allow informed consent Exclusion Criteria: * Pregnancy or plans to become pregnant during participation in the study * Not using effective birth control methods to prevent pregnancy * Breastfeeding for any infant milk feedings * Mother is not currently living with the infant during the trial period * Multiple birth (twin, triplet or greater)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}
Updated at
2023-04-18

1 organization

1 product

2 indications

Organization
University of North Carolina, Chapel Hill
Product
Syntocinon
Indication
Substance Use Disorder
Indication
Pregnancy