CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)

Inclusion criteria

• Males and females aged ≥18
• Diagnosis of radicular CNCP (i.e. lumbar, cervical, thoracic)
• Maintained on stable dose opioid therapy for a minimum of 1 month

o Note: Morphine Equivalent Daily Dose (MEDD) will be calculated using 2 reference documents: Guideline and conversion table to calculate MEDD from Centers for Medicaid and Medicare Services (CMS); Guidelines from the Centers for Disease Control and Prevention (CDC) intended for calculating total daily dose of opioids for safer dosage of opioid pharmacotherapy

• Able to provide voluntary informed consent
• If a woman of childbearing potential or a man, are willing to use approved form of contraception from screening for duration of the trial

Exclusion criteria

• Exclusionary medical conditions (e.g., unstable cardiac, hepatic, renal, neurologic illness) or any medical illness that in the opinion of the study physician poses a potential medical danger to the participant
• Exclusionary laboratory abnormalities (clinically significant abnormalities of complete blood count or chemistries, significantly impaired liver function)
• Current substance use disorder (including Opioid Use Disorder) other than nicotine or caffeine
• At screening, a positive urine toxicology test for: amphetamines (AMP), barbiturates (BAR), buprenorphine (BUP), benzodiazepines (BZO), cocaine (COC), 3,4-methylenedioxymethamphetamine (MDMA), methamphetamine (MET), methadone (MTD), phencyclidine (PCP), and tetrahydrocannabinol (THC)
• At screening, an alcohol level greater than 0 on a breathalyzer
• Severe psychiatric conditions including past or current DSM5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder
• Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of suicide attempts
• Current use of recreational or medical cannabis or any product containing CBD
• Pregnancy or lactation
• Current use of concomitant medications metabolized primarily by CYP2C19 isoenzymes
• Current use of concomitant medications significantly or primarily metabolized by CYP3A4 with the potential for adverse drug-drug interactions with CBD (i.e., ketoconazole, rifampicin)
• Current use of concomitant medications with a narrow therapeutic window significantly or primarily metabolized by CYP2C9 with the potential for adverse drug-drug interactions with CBD (i.e., warfarin)
• Current use of concomitant medications known to have adverse drug-drug interactions with CBD (i.e., valproate) or the potential to cause significant drug-drug interactions (i.e., clobazam).
• Known allergy to CBD or any ingredient of the study compound
• Currently enrolled in a clinical trial assessing the effects of an anti-pain intervention