Maintaining IV Patency Throughout Pharmacokinetic Studies Through a Needle‐Free Blood Draw Device

ABSTRACT Pharmacokinetic (PK) studies require temporally precise measurements of drug concentrations in biological matrices, most commonly whole blood or plasma. However, repeated venous sampling may increase participant burden and complicate PK‐intensive study designs. Needle‐free blood collection devices that access peripheral intravenous (IV) catheters may provide an alternative approach to repeated venipuncture while maintaining sampling schedules and specimen quality. This pilot study evaluated the feasibility of integrating the PIVO Pro needle‐free blood collection device into a PK‐intensive human laboratory study of inhaled Δ 8 ‐tetrahydrocannabinol (Δ 8 ‐THC), Δ 9 ‐THC, and placebo. Participants completed a screening visit and three dosing visits conducted in a university research facility equipped with a full‐scale driving simulator. During each dosing visit, venous blood samples were collected at nine time points over approximately 8 h through an indwelling peripheral IV catheter using the PIVO device. All participants reported that study procedures, including blood collection, were acceptable. Approximately 40% of vascular access sites required replacement, most commonly within the first hour and typically associated with poor initial blood return. Despite slower flow compared with standard venipuncture, sampling was generally sufficient to maintain the PK sampling schedule. One mild adverse event related to vascular access (localized bruising) was observed. These findings demonstrate the operational feasibility of needle‐free blood collection through indwelling IV catheters in a PK‐intensive research protocol conducted outside a traditional clinical research unit. Further studies are warranted to compare analytical performance and access durability relative to conventional venous sampling approaches.