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Clinical trial

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

ID
Name
REB23-1128
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2025-09-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Tetrahydrocannabinol (THC) 25 mg
Other names:
Tetrahydrocannabinol
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.
Arms:
Cannabidiol (CBD) 50 mg
Other names:
Cannabidiol
Size
30
Primary endpoint
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
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
Eligibility criteria
Inclusion Criteria: * Age between 18 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-02-15

1 organization

2 products

1 indication

Organization
University of Calgary
Product
THC
Indication
Multiple Sclerosis
Product
CBD