Abstract: TH-PO1192
DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Crossover Trial
Session Information
- Late-Breaking Science Posters
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Collister, David Thomas, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
- Cherepak, Kathy, Chronic Disease Innovation Center, Winnipeg, Manitoba, Canada
- Tangri, Navdeep, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
- Walsh, Michael, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
Group or Team Name
- DISCO-POT Investigators.
Background
Uremic pruritus affects 50% of patients with kidney failure and negatively impacts quality of life. Itch often persists despite effective pharmacologic treatments. Cannabinoids may reduce pruritus. We evaluated nabilone, a synthetic cannabinoid, to treat uremic pruritus.
Methods
Eligible participants were adults age>25 years receiving in-center or home hemodialysis at least 2x weekly or peritoneal dialysis daily for at least 90 days and at least moderate itch defined by a mean worst visual analogue scale (VAS) >40mm during a 1-week screening period. Participants were randomly allocated to oral nabilone 0.5mg daily x 1 week then nabilone 0.5mg twice a day x 3 weeks or an identical placebo regimen. Then, after a 2-week washout, participants received an identical regimen of nabilone or placebo, whichever they did not receive in the first treatment period. The primary outcome was the difference in worst VAS over the last 24 hours over each 4 week crossover period.
Results
Of 14 participants randomized, the mean (SD) age was 60.5 (12.7) years, 4 (28.6%) were female sex, 8 (57.1%) had diabetes, and all were on hemodialysis for a mean (SD) of 3.29 (0.73) sessions per week for a mean (SD) 4.04 (0.50) hours/treatment. The mean (SD) worst VAS was 69mm (25). Baseline co-interventions included topical emollients in 12 (85.7%) and alpha 2 delta ligands in 7 (50%). Self-reported and pill count adherence was >90%. Nabilone did not reduce the worst VAS to a greater extent than placebo (Figure 1). The worst VAS was 4.79 (95% CI -3.95 to 13.5, p=0.28) higher with nabilone compared to placebo, indicating worse itch. Nabilone also had no effect on other measures of itch, sleep, quality of life or adverse events.
Conclusion
This small trial detected no effect of nabilone on uremic pruritus compared to placebo. (ClinicalTrials.gov NCT05180968)
Funding
- Government Support - Non-U.S.