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Cannabinoid

Nabilone 0.5 MG Oral Capsule for Itching (DISCO-POT Trial)

Phase 3

Waitlist Available

Led By David Collister, MD, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Awards & highlights

DISCO-POT Trial Summary

This trial will test whether nabilone, a synthetic marijuana derivative, is better than placebo at relieving itch in people undergoing hemodialysis.

Eligible Conditions

Itching
Kidney Failure

DISCO-POT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID

Secondary outcome measures

Change in health-related quality of life

Change in uremic pruritis severity

Effect of nabilone on sleep quality

+1 more

DISCO-POT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nabilone 0.5mgExperimental Treatment1 Intervention

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.

Group II: Oral placeboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nabilone 0.5 MG Oral Capsule

2022

Completed Phase 3

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,467 Total Patients Enrolled

Population Health Research InstituteOTHER

155 Previous Clinical Trials

679,898 Total Patients Enrolled

David Collister, MD, PhDPrincipal InvestigatorUniversity of Manitoba

Media Library

Nabilone (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05180968 — Phase 3

Itching Research Study Groups: Nabilone 0.5mg, Oral placebo

Itching Clinical Trial 2023: Nabilone Highlights & Side Effects. Trial Name: NCT05180968 — Phase 3

Nabilone (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180968 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the research history of Nabilone 0.5 MG Oral Capsule?

"Researchers are currently conducting 6 trials on Nabilone 0.5 MG Oral Capsule, 3 of which have reached Phase 3 testing. Most of the work is being done in Toronto, but there are 9 other locations where Nabilone 0.5 MG Oral Capsule studies are taking place."

Answered by AI

Are new participants currently being signed up for this experiment?

"Unfortunately, this study is not taking any more patients at the moment. The clinicaltrials.gov website reports that the last date for recruitment was May 16th, 2022. There are, however, 639 other trials currently looking for participants."

Answered by AI

How many individuals are receiving treatment as part of this research project?

"This particular trial is no longer enrolling patients. The listing for the study was first posted on June 1st, 2022 and updated for the last time on May 16th, 2022. There are other trials with similar parameters that are currently looking for participants; 633 clinical trials for pruritus and 6 for Nabilone 0.5 MG Oral Capsule."

Answered by AI

Do people often experience negative side effects from taking Nabilone 0.5 MG Oral Capsule?

"There is some evidence to support the efficacy of Nabilone 0.5 MG Oral Capsule, as it has progressed to Phase 3 in clinical trials. Furthermore, multiple rounds of data have been collected supporting its safety, so it receives a score of 3 from our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DIalysis Symptom COntrol-Pruritus Outcome Trial

David Collister 2022. "DIalysis Symptom COntrol-Pruritus Outcome Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180968.