DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT): A Multicenter Randomized Blinded Placebo Controlled Crossover Trial

RATIONALE & OBJECTIVE: Uremic pruritus affects up to 50% of patients with kidney failure and negatively impacts quality of life. Itch often persists and remains insufficiently controlled despite standard of care treatments. We evaluated the effects of nabilone, a synthetic cannabinoid, in patients with kidney failure receiving dialysis who had symptoms of chronic itch. STUDY DESIGN: Placebo-controlled randomized crossover trial. SETTING & PARTICIPANTS: Adults ≥25 years old receiving maintenance hemodialysis at least twice weekly or peritoneal dialysis daily with at least moderate itch. INTERVENTIONS: Participants were randomly allocated to a first treatment period of either oral nabilone (0.5 mg daily for 1 week then twice a day for 3 weeks) or an identical placebo regimen. After a 2-week washout period, participants received whichever regimen they did not receive in the first treatment period. OUTCOMES: The primary outcome was the difference in worst visual analog score (0 to 100 mm) for itch over the last 24 hours in each treatment period. RESULTS: Of 14 participants randomized, all were receiving hemodialysis. The worst visual analog score for the nabilone compared to the placebo was 4.88 mm (95% CI, -3.61 to 13.38, P = 0.28), indicating worse itch with nabilone. The study was not able to detect any differences in nabilone compared with placebo in other measures of itch, sleep, quality of life, or adverse events. LIMITATIONS: Underpowered for secondary outcomes and to detect carryover effects, conservative nabilone dosing, short duration and a limited sample. CONCLUSIONS: We were unable to detect if nabilone had any effects on uremic pruritus compared with placebo.