Table 2.
Secondary and exploratory efficacy assessments.
| Test | Symptom | Type of outcome |
|---|---|---|
| Modified Ashworth Scale (42) | Spasticity, as assessed by a clinician | ClinRO |
| Expanded Disability Status Scale (43) | Disability | |
| Positive and Negative Syndrome Scale (45) | Psychotic symptoms | |
| Multiple Sclerosis Quality of Life Inventory (46, 47), includinga: | PRO | |
| MOS Pain Effects Scale (46, 47) | Pain | |
| Modified Fatigue Impact Scale – 5-Item Version (46, 47) | Fatigue | |
| Bowel Control Scale (46, 47) | Bowel dysfunction | |
| Bladder Control Scale (46, 47) | Bladder dysfunction | |
| Modified Social Support Survey – 5-Item Version (46, 47) | Perceived social support | |
| Sexual Satisfaction Scale (46–48) | Sexual dysfunction | |
| 36-Item Short Form Survey (46, 47) | Quality of life | |
| Perceived Deficits Questionnaire (46, 47, 49) | Subjective cognitive function | |
| Pittsburgh Sleep Quality Index (50) and Epworth Sleepiness Scale (51) | Sleep issues, according to the assessment of sleep quality and sleepiness, respectively | |
| Restless Legs Syndrome Severity Rating Scale (52, 53) | Restless legs syndrome’s severity | |
| Hospital Anxiety and Depression Scale (54, 55) | Anxiety and depression | |
| Cannabis Experience Questionnaire (56, 57)b | Euphoric and paranoid-dysphoric effects of cannabis | |
| Battery of cognitive tests: Montreal Cognitive Assessment (58), Brief Visuospatial Memory Test–Revised (59), D-KEFS Color-Word Interference Test (60), Hopkins Verbal Learning Test–Revised (61), The Trial Making Test A/B (62), and Symbol Digit Modalities Test (63) | Objective cognitive function | PerfO |
| Timed 25 Foot-Walk test (64–66) | Mobility |
ClinRO, clinician-reported outcome; PRO, patient-reported outcome; PerfO, performance outcome. aWe adapted the Multiple Sclerosis Quality of Life Inventory for the CANSEP trial, by excluding two of its ten scales: (1) The Impact of Visual Impairment Scale was not included, because it is not widely used in clinical practice and not relevant to the CANSEP trial; (2) instead of the Mental Health Inventory, we considered the Hospital Anxiety and Depression Scale, a widely used instrument in clinical practice, but also a validated scale in the MS population (55, 67, 68). Furthermore, we added the Cannabis Experience Questionnaire for the subjective effects of cannabinoids (56, 57). bAll tests will be conducted at baseline, at week 4, and at week 16. However, participants who never used cannabis in their lifetime will not complete the Cannabis Experience Questionnaire at baseline.