Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

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 severe depression Current suicidal ideation Diagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury) Uncontrolled hypertension (\>139/89) Abnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician Known hepatic disease or dysfunction, or identification of such on screening laboratory studies Known cardiovascular disease Abnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD Cognitive disability that interferes with ability to provide consent or understand study procedure History of seizure disorder Any medical condition for which immunosuppressive therapy is required. Inability to refrain from using tobacco for at least 4 hours Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data Pending legal action or workers compensation Pregnant females or …