Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-12-05
2026-09-30
Brief Summary
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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.
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Detailed Description
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Cannabis and cannabis-based medicines (CBM) are often used by persons with MS (PwMS).
Cannabis research to date indicates that its use worsens cognitive function in PwMS. Additionally, cognitive impairment (CI) is already a frequent consequence of MS, with a significant negative impact on quality of life (QOL).
This is pilot randomized, double blinded, double arm clinical trial of Tetrahydrocannabinol (THC) 25 mg or Cannabidiol (CBD) 50 mg orally for 15 weeks in people with MS trial.
The investigators will recruit PwMS with symptoms of neurogenic lower urinary tract dysfunction (NLUTD). These participants can either be on a treatment that has been only partially effective (as per patient report) or has never tried an intervention for their NLUTD symptoms.
The primary aim is to evaluate the differential effect of the tetrahydrocannabinol (THC) and cannabidiol (CBD) on cognitive outcomes in persons with Multiple Sclerosis (PwMS) using cannabis for NLUTD.
The results of our proposed study will better inform both healthcare practitioners and patients with respect to the potential risks of treatment with cannabis-based products and any difference with respect to THC vs. CBD-based products.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tetrahydrocannabinol (THC) 25 mg
THC oil will be administered orally once a day for 15 weeks.
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.
Cannabidiol (CBD) 50 mg
CBD oil will be administered orally once a day 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
59 Years
ALL
No
Sponsors
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Multiple Sclerosis Society of Canada
OTHER
University of Calgary
OTHER
Responsible Party
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Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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Other Identifiers
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REB23-1128
Identifier Type: -
Identifier Source: org_study_id
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