A Phase 1 interventional study of Syntocinon treatment and Placebo in Substance Abuse Problem and Pregnancy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Basic science
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.
Participation for mothers when they are 3-6 months postpartum includes:
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 31 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Syntocinon spray, 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).
Drug: Syntocinon treatment
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Other: Placebo
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).
Also known as: Nasal Oxytocin treatment
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
Time frame: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.
Time frame: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.
Time frame: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.
Time frame: 2 weeks
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill