drugset / Trial / NCT04816994

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

NCT04816994

Phase 3 Recruiting 200 enrolled Hadassah Medical Organization
RandomizedSequentialSingle-blindTreatment

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.

Timeline

Start
2018-01-07
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 10 mg Other
Subject Cannabidiol Other / unclassified 20 mg Other
Subject Dronabinol Other / unclassified 10 mg Other
Subject Dronabinol Other / unclassified 20 mg Other

Indications