Cannabis (THC vs. CBD) in Multiple Sclerosis
Recruiting · NCT06261489 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
26 Years to 59 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- University of Calgary Foothills Medical Center - Calgary, Alberta, Canada
- University of Calgary - Calgary, Alberta, Canada