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DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05180968
Recruitment Status : Not yet recruiting
First Posted : January 6, 2022
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
David Collister, University of Manitoba

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Pruritus Drug: Nabilone 0.5 MG Oral Capsule Drug: Placebo Nabilone Phase 3

Detailed Description:

Several different types of medications are effective in treating uremic pruritus, but even with effective treatments, residual symptoms are common and some medications are not well tolerated. Standard of care treatments include emollients which are lotions that keep the skin hydrated and a variety of pills that target the itch pathways implicated in the disease.

The objective of the study is to determine the proportion of patients with kidney failure for whom oral nabilone provides important benefit in reducing uremic pruritis without important adverse effects. The hypothesis is that there is a substantial proportion of patients in whom oral nabilone are safe and effective beyond placebo effects.

Nabilone is currently used to treat conditions other that uremic pruritus including chronic nerve pain as well as nausea and vomiting due to chemotherapy. It has never been studied in the setting of kidney disease.

DISCO-POT is a blinded, placebo-controlled crossover trial in which participants will be followed for 11 weeks including two 4 week treatment crossover periods with a 2 week washout period in between them and an end of study visit after 1 week off study drugs.

Patients that are eligible will be randomly assigned to a crossover treatment sequence of two treatments:

  1. nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated)
  2. placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching
Drug Information available for: Nabilone

Arm Intervention/treatment
Experimental: Nabilone 0.5mg
Subjects will receive nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.
Drug: Nabilone 0.5 MG Oral Capsule
This intervention will consist of subjects receiving nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks. Duration of the intervention will be 4 weeks.
Other Name: TEVA-Nabilone

Placebo Comparator: Oral placebo
Subjects will receive placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.
Drug: Placebo Nabilone
This intervention will consist of subjects receiving placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks. Duration of the intervention will be 4 weeks.
Other Name: TEVA-Nabilone Placebo




Primary Outcome Measures :
  1. Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID [ Time Frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10 ]
    Measured using Visual Analogue Scale (VAS)


Secondary Outcome Measures :
  1. Number of participants with safety outcomes including adverse events related to study drug [ Time Frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11 ]
    serious adverse events, adverse events leading to drug discontinuation, hospitalization or emergency room visit for altered level of consciousness, fall, fracture, death, symptomatic hypotension requiring an intervention

  2. Change in uremic pruritis severity [ Time Frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10 ]
    Measured as change from baseline in mean Visual Analogue Scale (VAS)

  3. Change in uremic pruritis severity [ Time Frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10 ]
    Measured as change from baseline in mean Verbal Rating Scale (VRS)

  4. Change in health-related quality of life [ Time Frame: Measured at study baseline and weeks 3 and 4 of each crossover ]
    Measured using the Dermatology Quality of Life Index (DLQI)

  5. Change in health-related quality of life [ Time Frame: Measured at study baseline and weeks 3 and 4 of each crossover ]
    Measured using the EQ-5D 5 Level (EQ-5D-5L)

  6. Change in health-related quality of life [ Time Frame: Measured at study baseline and weeks 3 and 4 of each crossover ]
    Measured using the Patient Global Impression (PGI)

  7. Effect of nabilone on sleep quality [ Time Frame: Measured at study baseline and weeks 3 and 4 of each crossover ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05180968


Contacts
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Contact: Mark Pinder, MSc 204-631-3834 mpinder2@sogh.mb.ca

Locations
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Canada, Manitoba
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada, R2V 3M3
Contact: Mark Pinder, MSc    204-631-3834    mpinder2@sogh.mb.ca   
Principal Investigator: David Collister, MD, PhD         
Sponsors and Collaborators
University of Manitoba
Population Health Research Institute
Investigators
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Principal Investigator: David Collister, MD, PhD University of Manitoba
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Responsible Party: David Collister, Adjunct Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT05180968    
Other Study ID Numbers: B2021:096
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Collister, University of Manitoba:
Uremic
Pruritis
Itch
End Stage Renal Disease
Dialysis
Nabilone
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Pruritus
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Skin Diseases
Skin Manifestations
Dronabinol
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hallucinogens
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists