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Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study
Led by Hadassah Medical Organization · Updated on 2025-10-02
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of cannabis extract, specifically a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD), on acute radicular back pain and renal colic pain. The study aims to evaluate whether cannabis can reduce pain and decrease the need for opioid painkillers in patients experiencing strong nerve-related pain or pain due to kidney stones. This is a randomized, double-blinded clinical trial including adult patients hospitalized for these acute pain conditions. Participants will receive one of several treatments: a high dose of cannabis oil (21.6 mg THC and 20 mg CBD), a split high dose given one hour apart, a low dose (10.8 mg THC and 10 mg CBD), or a placebo consisting of olive oil with a similar taste and appearance. All patients will also receive standard pain management with morphine via a patient-controlled analgesia (PCA) pump over 24 hours. The treatments are administered under the tongue, and blinding is maintained for patients, researchers, and analysts. During the study, patients will be monitored for their opioid consumption over 24 hours using the PCA pump, which is the primary outcome. Secondary outcomes include changes in nausea, vomiting, anxiety, and pain intensity measured by visual analog scales (VAS). Safety and effectiveness will be assessed throughout the 24-hour follow-up period while patients continue their standard care. The study is sponsored by Hadassah Medical Organization and includes adults aged 18 to 70 years with acute radicular pain or renal colic.
CONDITIONS
Brief Title
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- ASA physical status classification 1 or 2
- Acute radicular pain lasting less than 12 weeks
- Pain score of 6 or more on the Visual Analog Scale or moderate or more on the Verbal Rating Scale
- Radicular pain matching physical exam and CT/MRI findings within the last year
You will not qualify if you...
- Age younger than 18 or older than 70 years
- ASA physical status classification 3 or higher
- Chronic radicular pain lasting more than 12 weeks
- Past spine surgery
- Intermittent claudication due to vascular disease
- Diagnosed diabetic neuropathy
- Regular cannabis use in the past 6 months or once in the last 2 weeks
- Regular opioid use equivalent to 20 mg or more of oxycodone per day in the past week
- Pregnancy or lactation
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours
Participants receive a single dose of cannabis oil or placebo to treat acute radicular pain while also receiving standard morphine treatment via a patient-controlled analgesia pump for 24 hours.
1 treatment and observation period lasting 24 hours
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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