Assessment of the physical dependence potential of difelikefalin: Randomized placebo-controlled study in patients receiving hemodialysis.

ABSTRACT: Difelikefalin is a selective kappa opioid receptor agonist approved for treating moderate-to-severe pruritus in adults undergoing hemodialysis (HD). Difelikefalin is not a controlled substance under the Controlled Substances Act. This study assessed the potential for developing physical dependence on difelikefalin in patients undergoing HD. Eligible patients received open-label difelikefalin after each dialysis session for 3 weeks before entering a 2-week double-blind phase, when they were randomized to either continue difelikefalin or to switch to receiving placebo. Signs of physical withdrawal were assessed using the Clinical Opiate Withdrawal Scale (COWS), several patient-reported scales, and physiological measures. The primary end point was the between-group difference in mean maximum

SUBMITTER: Spencer RH 

PROVIDER: S-EPMC10499405 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature