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

NCT04816994 | Recruiting Phase 3 DMC

• 1 other identifier: 0092-17-HMO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 and for renal colic.

Conditions

Acute Radicular Back Pain; Cannabis

Keywords

Acute radicular back pain; Cannabis

Outcome Measures

Primary Outcomes (1)

• opioid consumption via - Patient controlled administration (PCA)

  Count of patient-controlled analgesia pushes.

  The change over 24 hours

Secondary Outcomes (3)

• Nausea and vomiting (PONV) score

  The change over 24 hours

• Anxiety - VAS

  The change over 24 hours

• VAS

  The change over 24 hours

Study Arms (3)

High dose cannabis oil

EXPERIMENTAL

Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic.

Drug: Single-dose of cannabis oil

Low dose cannabis oil

EXPERIMENTAL

Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.

Drug: Single-dose of cannabis oil

Control

PLACEBO COMPARATOR

Single-dose Olive oil that is similar in appearance and taste to cannabis oil

Drug: Control

Interventions

Single-dose of cannabis oil DRUG

Single-dose of cannabis oil in order to treat acute radicular pain

High dose cannabis oil; Low dose cannabis oil

Control DRUG

Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 25, 2021
• Study Start: January 7, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)