Human Abuse Potential

HAP clinical studies, also referred to as human abuse liability (HAL) studies, may be mandated by the FDA to evaluate the safety of New Chemical Entities (NCEs) with CNS activity, similarity to drugs with known abuse potential, or psychoactive effects like sedation or euphoria.

Additionally, sponsors may need to assess Abuse-Deterrent Formulations (ADFs) to gauge their resistance to tampering and abuse compared to non-deterrent products or other approved ADFs. These trials often follow a 505(b)(2) strategy. Due to the intricate regulatory requirements and protocol designs for HAP and ADF studies (including comparator selection and recruitment), tailored consulting is essential for each study type.