Cannabis (THC vs. CBD) in Multiple Sclerosis

NCT06261489 | Active Not Recruiting Phase 2

• 1 other identifier: REB23-1128
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Cannabis; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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 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.

  15 weeks

Study Arms (2)

Tetrahydrocannabinol (THC) 25 mg

EXPERIMENTAL

THC oil will be administered orally once a day for 15 weeks.

Drug: THC

Cannabidiol (CBD) 50 mg

EXPERIMENTAL

CBD oil will be administered orally once a day for 15 weeks.

Drug: CBD

Interventions

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.

Also known as: Tetrahydrocannabinol

Tetrahydrocannabinol (THC) 25 mg

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.

Also known as: Cannabidiol

Cannabidiol (CBD) 50 mg

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis; Marijuana Abuse

Interventions

Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 15, 2024
• Study Start: December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CA (1)