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.
Detailed Description
This randomized, placebo-controlled clinical trial is designed to elucidate the role of extended oral cannabis treatment in the alleviation of chronic spine pain and reduction of high-dose opioid use. This trial includes two study arms: Analgesia Arm and Reduction Arm. The Analgesia Arm uses a within-subject crossover design to determine whether daily treatment with an oral cannabis solution for 6 weeks significantly reduces spine pain compared to placebo. The Reduction Arm uses a parallel design to determine whether daily treatment with an oral cannabis solution for 13 weeks results in a greater reduction of pain and opioid intake than placebo treatment. It will also assess the impact of extended cannabis treatment on opioid craving and symptoms of opioid withdrawal in participants tapering their high-dose opioids.
Eligibility Criteria
Age Range: 21 years to 84 years
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 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.