Health TrialsbyHealthPanel

Cannabis (THC vs. CBD) in Multiple Sclerosis

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age26-59
SponsorUniversity of Calgary

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • THC

    Drug

    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

    Drug

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Tetrahydrocannabinol (THC) 25 mgExperimental treatment 1 intervention
Group B: Cannabidiol (CBD) 50 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT).

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.

Time frame
15 weeks
2

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).

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.

Time frame
15 weeks

Secondary outcomes

1

Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report.

The investigators will ask subjects at each visit to try and identify which arm they were randomized to. If participants feel they are able to determine which group they were assigned to, they will be asked to identify how/why. This data will help investigators to develop better masking in our subsequent study.

Time frame
15 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Multiple Sclerosis Society of Canada

Collaborator

Source ClinicalTrials.gov
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