Nasal Oxytocin Trial to Assess Maternal Psychophysiology in Mothers with Prenatal Cocaine Exposure

Maternal substance use during pregnancy, particularly cocaine, poses significant risks to both mother and child, often leading to impaired maternal caregiving behaviors and disrupted mother-infant bonding. These challenges can stem from alterations in brain reward and stress systems, which are critical for nurturing responses. Current interventions often focus on behavioral therapies, but pharmacological approaches targeting underlying neurobiological deficits are also being explored. Oxytocin, a neuropeptide known for its crucial role in social bonding, attachment, and stress regulation, has shown promise in modulating these systems. Dysregulation of the oxytocin system is implicated in various psychiatric conditions, including substance use disorders and impaired social cognition. This study aims to explore whether exogenous oxytocin administration can mitigate the negative impacts of prenatal cocaine exposure on maternal psychophysiology and behavior, addressing a critical gap in supporting vulnerable mother-infant dyads.

This research is a prospective, double-blind, placebo-controlled trial involving 32 mothers with documented prenatal cocaine use during their current pregnancy. Participants will be enrolled at 3-6 months postpartum and will complete 3 study visits over a 2-week period. During this time, they will undergo a double-blind trial of twice-daily nasal spray administration, receiving either nasal oxytocin or a placebo. The specific dose of oxytocin is not detailed in the abstract, but the route and frequency are clear. The study will also include 4 telephone interviews to gather additional data. The primary objective is to study the effects of this intervention on maternal behaviors and psychophysiology, with all collected information maintained confidentially. This design allows for a controlled assessment of oxytocin's potential impact.

This abstract describes the purpose and design of a clinical trial protocol. As such, no results or findings are available from this study at this stage. The research is designed to investigate the effects of nasal oxytocin, but the outcomes have not yet been reported.