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, 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.