The Differential Effects of THC vs. CBD on Cognition in Persons With MS

NCT06261489 Phase 2 ACTIVE_NOT_RECRUITING

The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS). Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks.

Details

Lead sponsor	University of Calgary
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	30
Start date	2025-12-05
Completion	2026-09

Conditions

• Multiple Sclerosis

Interventions

• THC
• CBD

Primary outcomes

• Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT). — 15 weeks
  Symbol Digit Modality Test (SDMT) is an assessment of the information processing speed. It consists of the presentation of a standard letter sized paper (8.5 × 11 in.) that contains the numbers and symbols to be processed. At the top of the page is a key where nine symbols are each paired with a single digit. The remainder of the page has a pseudorandomized sequence of these symbols. In the oral version of the SDMT, adapted for the MS population by Rao, the subject responds orally with the digit associated with each of the symbols as quickly as possible, and is scored as the total number of correct responses in 90s.Participants will be evaluated at baseline, week 10 and week 15.
• NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS). — 15 weeks
  Neurogenic Bladder Symptom Score (NBSS) is a validated measure of bladder symptoms and QoL. It is scored from 0 (no symptoms) to 74 and has 3 domains: incontinence; storage, voiding, and consequences; and a single overall QOL question. Participants will be evaluated at baseline, week 10 and week 15.

Countries

Canada