THC: Participants will be randomly assigned to the study treatment. THC dose will be gradually increased until 25 mg. Treatment will be taken orally at bedtime for 15 weeks.
CBD: Participants will be randomly assigned to the study treatment. CBD dose will be gradually increased until 50 mg. Treatment will be taken orally at bedtime for 15 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
26 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 26 and 59 years inclusive.
* Confirmed diagnosis of Multiple Sclerosis as per McDonald criteria (any type) \[12\]
* Symptoms of neurogenic lower urinary tract dysfunction (NLUTD) as measured by neurogenic bladder symptom score (NBSS), with a minimum score of 7.
* If already on a medication for NLUTD, must be stable on this medication for at least 4 weeks.
* Sexually active men and women of child-bearing potential must agree to use adequate contraception.
* Written informed consent.
Exclusion Criteria:
* Major psychiatric disorder such as schizophrenia or bipolar disorder
* Major neurological disorder which could affect cognition such as dementia, traumatic brain injury.
* Seizure disorder
* Use of antipsychotic medication
* Use of benzodiazepines other than exclusively at night/bedtime
* Experienced a MS relapse in the last ninety (90) days.
* Current use of cannabis or CBM greater than 3x/week.
* Currently using cannabis/CBM less than 3x/week and being unwilling to abstain for the duration of the study.
* Visual acuity (binocular) worse than 20/70 (in order to complete the cognitive outcomes)
* Significant upper extremity disability that would interfere with the cognitive tests battery.
* Indwelling catheter use/urinary diversion
* Pregnant or Breastfeeding
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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