Safety and Efficacy of Oral Cannabis in Chronic Spine Pain (NCT05052541) | Clinical Trial Compass
RecruitingPhase 3
Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
United States157 participantsStarted 2026-01
Plain-language summary
The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.
Who can participate
Age range21 Years – 84 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Inclusion Criteria:
Self-reported chronic (≥3 months' duration), non-radicular spine pain
Exclusion Criteria:
Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and topicals.
Co-morbid cancer-related pain condition
Neuropathic Pain
A co-morbid pain condition that is of greater severity than the patient's spine pain
Spine or other major surgery within the 3 months prior to enrollment
Planned surgery or procedural intervention during the study period
Allergy or adverse reaction to cannabis
Current or historical substance use disorder
Current or historical alcohol use disorder
Current or prior cannabis abuse/dependence
Positive result for use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen
Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines
Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)
History or diagnosis of schizophrenia, bipolar or a psychotic disorder
History of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant
Current or historical se…
What they're measuring
1
Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain
Timeframe: Weekly, up to week 22
2
Change in opioid dose as measured in morphine milligram equivalents (MME)