Overview

DIalysis Symptom COntrol-Pruritus Outcome Trial

Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test whether or not a medication called nabilone, which is a synthetic (non-natural) medication derived from cannabis, compared to placebo improves symptoms of itch in hemodialysis as measured by visual analog scales.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Manitoba
Collaborator:
Population Health Research Institute
Treatments:
Dronabinol
Nabilone
Criteria
Inclusion Criteria:

1. Age>25 years

2. In-center or home hemodialysis at least two times weekly or peritoneal dialysis at
least once daily for >90 days

3. Generalized uremic pruritus with a mean worst VAS>40mm over the previous week (with at
least 5/7 patient diary days completed)

4. ALT less or equal to 3x upper limit of normal and bilirubin less than or equal to 2x
upper limit of normal in the last 90 days

5. Able to provide informed consent and complete patient reported outcome measurements
without a language barrier or cognitive impairment

Exclusion Criteria:

1. Etiology of pruritus (in the opinion of the treating physician) thought to be
secondary to primary dermatologic condition, liver disease, hematologic malignancy or
allergy

2. Use of recreational or medical cannabis in the last 4 weeks (THC, CBD, nabilone,
Sativex, Epidiolex)

3. Women of childbearing potential as assessed by their clinician regardless of
abstinence from sex or the use of contraception

4. Planned kidney transplantation, travel or relocation in the next 3 months

5. Unstable psychiatric illness (the presence of a lifetime diagnosis of a psychotic
disorder, bipolar disorder, substance use disorder or current suicidal ideation)

6. Symptomatic hypotension in the last 2 weeks defined as a systolic blood pressure (SBP)
less than 90mmHg during or in between dialysis requiring an intervention (i.e.
administration of crystalloid or colloid, termination of dialysis, change in
pharmacologic therapy such as withdrawal of anti-hypertensive therapy or
initiation/titration of midodrine, increase in dry weight)

7. History of hypersensitivity to any cannabinoid

8. Presence of any clinically significant or unstable medical conditions, including
cardiovascular, liver, pulmonary disease