Cannabis (THC vs. CBD) in Multiple Sclerosis

February 7, 2024 updated by: University of Calgary

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system.

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tetrahydrocannabinol (THC) 25 mg
THC oil will be administered orally once a day for 15 weeks.
Drug: 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.
Other Names:
  • Tetrahydrocannabinol
Experimental: Cannabidiol (CBD) 50 mg
CBD oil will be administered orally once a day for 15 weeks.
Drug: 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 Names:
  • Cannabidiol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report.
Time Frame: 15 weeks
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.
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Multiple Sclerosis Society of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB23-1128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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