Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement

Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study

Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention.

Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain

Study Overview

• Status: Unknown
• Conditions: Cannabis; Acute Radicular Back Pain
• Intervention / Treatment: Drug: Single-dose of cannabis oil; Drug: Control

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Center
    • Contact: Elyad M Davidson, M.D; Phone Number: 54211 972-2-6776911; Email: edavidson@hadassah.org.il
    • Principal Investigator: Elyad M Davidson, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 70 years
• ASA 1 or 2
• Acute Radicular Pain < 12 weeks
• Pain of VAS 6 or more/ VRS moderate or more
• Radicular pain: Dermatomal pain that corresponds to physical exam and CT/MRI in the last year

Exclusion Criteria:

• Age < 18 or > 70 years
• ASA 3 or more
• Chronic radicular pain > 12 weeks
• Past spine surgery
• Intermittent Claudication due to Vascular Disease
• Diagnosed Diabetic Neuropathy
• Regular Cannabis use in past 6 months (more than once a week) OR once in last 2 weeks
• Regular opioid use in past week (Targin, Percocet, Tramadol) (Equivalent to Oxycodone 20 mg/day or more)
• Pregnancy or Lactating
• Ischemic heart disease
• Renal or hepatic failure
• History of psychiatric illness
• Cognitive impairment or inability to answer questions
• Known allergy to opioids
• Potential Loss to follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose cannabis oil; Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic.	Drug: Single-dose of cannabis oil; Single-dose of cannabis oil in order to treat acute radicular pain
Experimental: Low dose cannabis oil; Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.	Drug: Single-dose of cannabis oil; Single-dose of cannabis oil in order to treat acute radicular pain
Placebo Comparator: Control; Single-dose Olive oil that is similar in appearance and taste to cannabis oil	Drug: Control; Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radicular pain- VAS	Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.	The change over 24 hours
opioid consumption via - Patient controlled administration (PCA)	Count of patient-controlled analgesia pushes.	The change over 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea and vomiting (PONV) score	PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.	The change over 24 hours
Anxiety - VAS	Self-assessed anxiety visual analog scale (0-100 mm). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.	The change over 24 hours

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cannabis; Acute radicular back pain
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Back Pain; Marijuana Abuse
• Other Study ID Numbers: 0092-17-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No