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

• ClinicalTrials.gov Identifier: NCT04816994
• Recruitment Status: Recruiting
• First Posted: March 25, 2021
• Last Update Posted: March 25, 2021
• Sponsor: Hadassah Medical Organization
• Information provided by (Responsible Party): Elyad Davidson, Hadassah Medical Organization

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Acute Radicular Back Pain; Cannabis	Drug: Single-dose of cannabis oil; Drug: Control	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study
• Actual Study Start Date: January 7, 2018
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Israel

Hadassah Medical Center; Recruiting

Jerusalem, Israel

Contact: Elyad M Davidson, M.D 972-2-6776911 ext 54211 edavidson@hadassah.org.il

Principal Investigator: Elyad M Davidson, M.D

Sponsors and Collaborators

Hadassah Medical Organization

More Information

• Responsible Party: Elyad Davidson, Director Pain Relief Unit, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT04816994
• Other Study ID Numbers: 0092-17-HMO
• First Posted: March 25, 2021
• Last Update Posted: March 25, 2021
• Last Verified: March 2021

• 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

Keywords provided by Elyad Davidson, Hadassah Medical Organization:

Acute radicular back pain; Cannabis

Additional relevant MeSH terms:

Back Pain; Marijuana Abuse; Pain; Neurologic Manifestations; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders