RecruitingPhase 2MS (type not specified)NCT06261489

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Dronabinol

    Cannabinoid CB1 receptor agonist

  • Cannabidiol

    Cannabinoid CB1 receptor negative allosteric modulator

What it measured

Main measures

  • 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

    Thinking and memory
  • 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

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Other measures (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

    Feasibility

Who could take part

MS (type not specified) · 26 to 59

Inclusion Criteria: * 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. * 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Dec 2025

      2. Main results due

        Sept 2027

      3. Finished

        Sept 2027

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