A Phase I/II Randomized Double-Blind Placebo-Controlled Trial of Cannabidiol for chronic radiculopathic pain syndromes maintained on chronic opioid therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Radiculopathic Pain Syndromes
  • Age: Between 18 years - 90 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of radicular chronic non-cancer pain (CNCP) (i.e., lumbar, cervical, thoracic)
    2. Maintained on moderate to high dose opioid therapy [morphine-equivalent daily dose (MEDD) = 50 mg/d] for a minimum of 3-months
    3. Express a motivation to decrease their opioid analgesic maintenance dose
    4. Willingness to allow for initial and ongoing communication between study team and treatment provider(s) prescribing chronic opioid therapy for radicular CNCP
    5. Able to provide written informed consent
    6. If a woman of childbearing potential or a man, are willing to use approved form of contraception from screening for duration of the trial

You may not be eligible for this study if the following are true:

    1. 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
    2. Exclusionary laboratory abnormalities
    3. Current substance use disorder (including Opioid Use Disorder) other than nicotine or caffeine
    4. Severe psychiatric conditions including past or current DSM5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder
    5. Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization
    6. Current use of recreational or medical cannabis or any product containing CBD
    7. Pregnancy or lactation
    8. Current use of concomitant medications metabolized primarily by CYP2C19 isoenzymes
    9. Current use of concomitant medications significantly or primarily metabolized by CYP3A4 with the potential for adverse drug-drug interactions with CBD
    10. 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
    11. 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
    12. Known allergy to CBD or any ingredient of the study compound
    13. Currently enrolled in a clinical trial assessing the effects of an anti-pain intervention



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