Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT01748695
Eligibility Criteria:
Inclusion Criteria:
* aged 18 - 65 years
* documented spinal cord injury at or below T5
* moderate pain at or below the level of the spinal cord injury for at least 3 months
* compliant with daily diary
* stable pain scores on the NRS
* mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS score is \>9, the mean Gracely score must be ≤19)
Exclusion Criteria:
* women of child-bearing potential
* men who intend to father a child
* a history of multiple drug allergies, hypersensitivity to any cannabinoid
* an increased risk of seizure
* evidence of depression and/or a score of \>19 on the BDI-II
* suicidal ideation or suicidal behavior in the past 10 years
* a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
* a positive urine test for cannabis at screening
* taking excluded medications that cannot be stopped
* a positive pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01748695
Study Brief:
Protocol Section:
NCT01748695