Oral Oxytocin Lollipop Investigated for Peripheral Concentration Increase and Social Attention Modulation

Oxytocin, a neuropeptide, plays a crucial role in social cognition, bonding, and stress regulation. While intranasal and lingual spray administrations are common for research and off-label use, they often suffer from inconsistent absorption, variable bioavailability, and user compliance issues. Exploring novel, more user-friendly delivery methods like oral administration via a medicated lollipop could offer a significant advantage, potentially improving drug delivery consistency and patient acceptance for modulating social attention and other oxytocin-mediated behaviors.

This triple-blind, placebo-controlled, randomized basic science study enrolled 72 adult male subjects to compare an oral oxytocin lollipop against a placebo. Participants were randomly allocated to receive either an oral lollipop with oxytocin (24IU) or an identical placebo lollipop. Blood samples (5ml) were collected immediately before and 30 minutes after a 3-minute lollipop administration. Following a 30-minute rest, participants engaged in an anti-saccade attention task 45 minutes post-administration, with mood assessed via PANAS before and after the experiment.

As this is a trial registration (NCT05444738) and the study status is UNKNOWN, specific findings are not yet available. However, the study aims to investigate several key outcomes. The primary objective is to determine if oral 24IU oxytocin delivered via a medicated lollipop significantly increases peripheral oxytocin concentrations compared to placebo. Secondary outcomes include assessing the modulation of social attention using an anti-saccade paradigm and evaluating changes in mood via the Positive Affect Negative Affect Scale (PANAS). The researchers hypothesize that the oral lollipop will achieve similar peripheral concentrations and attention modulation effects as previously observed with intranasal or lingual routes. This trial will provide critical data on the pharmacokinetic profile and initial efficacy of this novel delivery method. The study design includes rigorous controls to ensure the reliability of future results. The anti-saccade task is a well-established measure of inhibitory control and attention, often influenced by oxytocin.