Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

Exclusion Criteria35

• 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 females intending to become pregnant during the study period
• Unwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of childbearing potential)
• Lactating females
• Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study
• Not interested in reducing or discontinuing use of prescribed opioids for chronic pain
• Unwilling to allow the study team to communicate with the participant's opioid prescribing provider