Recruiting
Phase 2

THC & CBD

Sponsor:

University of Calgary

Code:

NCT06261489

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Interventions

THC

CBD

Study Details

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

Study ID

NCT06261489

Start date

Dec 5, 2025

Status verified date

Sep, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tetrahydrocannabinol (THC) 25 mg

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

experimental: Cannabidiol (CBD) 50 mg

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

Interventions

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.

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.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Sarah A Morrow, MD, MS, FRCPC, FAAN

1-403-9444241sarah.morrow@albertahealthservices.ca

Graziela Cerchiaro, PhD, CCRP

1-403-9444315graziela.cerchiaro@albertahealthservices.ca

Locations

University of Calgary Foothills Medical Center

Recruiting

Calgary, Alberta, Canada

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Sarah A Morrow

1-403-9444241sarah.morrow@albertahealthservices.ca

More Information

Sponsor

University of Calgary

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Cannabis
  • Cognitive Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-09-09.