Nabilone 0.5 MG Oral Capsule for Itching

Seven Oaks General Hospital, Winnipeg, Canada
Itching+1 More ConditionsNabilone 0.5 MG Oral Capsule - Drug
Eligibility
18+
All Sexes

Study 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

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Week 1
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID
Change in uremic pruritis severity
Week 1
Number of participants with safety outcomes including adverse events related to study drug
Week 3
Change in health-related quality of life
Effect of nabilone on sleep quality

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Nabilone 0.5mg
1 of 2
Oral placebo
1 of 2

Experimental Treatment

Non-Treatment Group

12 Total Participants · 2 Treatment Groups

Primary Treatment: Nabilone 0.5 MG Oral Capsule · Has Placebo Group · Phase 3

Nabilone 0.5mg
Drug
Experimental Group · 1 Intervention: Nabilone 0.5 MG Oral Capsule · Intervention Types: Drug
Oral placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Nabilone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Who is running the clinical trial?

University of ManitobaLead Sponsor
556 Previous Clinical Trials
193,180 Total Patients Enrolled
Population Health Research InstituteOTHER
148 Previous Clinical Trials
674,309 Total Patients Enrolled
David Collister, MD, PhDPrincipal InvestigatorUniversity of Manitoba

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.