Status:
COMPLETED
CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Radiculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This double-blind, placebo-controlled, exploratory trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 20 outpatients with chronic spinal radiculopathies (without co-occurring O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04760613
Start Date
February 3 2022
End Date
June 7 2023
Last Update
September 19 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016