Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
Back Pain, Neck Pain
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
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:
Documented 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
Diagnosed autoimmune or rheumatological disease such as rheumatoid arthritis (RA) or multiple sclerosis (MS)
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
Analgesia Arm Exclusion Criteria:
Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study
Reduction Arm Exclusion Criteria:
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
*Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo
Analgesia Arm: THC, then Placebo, then THC/CBD
Analgesia Arm: THC/CBD, then THC, then Placebo
Analgesia Arm: THC/CBD, then Placebo, then THC
Analgesia Arm: Placebo, then THC, then THC/CBD
Analgesia Arm: Placebo, then THC/CBD, then THC
Reduction Arm: THC/CBD
Reduction Arm: Placebo
Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this parallel arm will be assigned to 13 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
Subjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.