Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial.

Publication date: Mar 12, 2020

Delta-9-tetrahydrocannabinol (?-THC) and other cannabinoids present in cannabis (marijuana) have been shown to affect the normal inhibitory pathways that influence nociception in humans. The potential benefits of cannabinoids as an analgesic are likely greatest in hyperalgesic and inflammatory states, suggesting a role as a therapeutic agent for treating acute pain following injury. Dronabinol is a licensed form of ?-THC. The primary objective of this single center randomized controlled trial is to evaluate the efficacy of adjunctive dronabinol versus control (systemic analgesics only, no dronabinol) for reducing opioid consumption in adults with traumatic injury. Study inclusion is based on high baseline utilization of opioids ?50 morphine equivalents (mg) within 24 h of admission for adults aged 18-65 years with traumatic injury. There is a 48-hour screening period followed by a 48-hour treatment period after randomization. A total of 122 patients will be randomized 1:1 across 2 study arms: adjunctive dronabinol versus control (standard of care using systemic analgesics, no adjunctive dronabinol). Patients randomized to the dronabinol arm should receive their first dose within 12 h of randomization, with a dose range of 5 mg up to 30 mg daily in divided doses, in addition to systemic analgesics as needed for pain. The primary efficacy endpoint is a change in opioid consumption (morphine equivalents), assessed post-randomization (48 h after randomization) minus pre-randomization (24 h prior to randomization). This is the first randomized trial to investigate whether adjunctive dronabinol is effective in reducing opioid consumption in acute pain management of traumatic injury. Trial Registration: ClinicalTrials.gov Identifier: NCT03928015.

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Swartwood, C., Salottolo, K., Madayag, R., and Bar-Or, D. Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. 04777. 2020 Brain Sci (10):3.

Concepts Keywords
Analgesic Aromatase inhibitors
Analgesics Entheogens
Cannabinoids Antiemetics
Cannabis Appetite stimulants
Dronabinol Euphoriants
Hyperalgesic Psychoactive drugs
Marijuana Medicine
Morphine Drugs
Nociception Acute pain management
Opioid Pain
Opioids Years traumatic injury
Pain Dronabinol
Pain Management Tetrahydrocannabinol
Randomization Opioid
Randomized Controlled Trial Analgesic
Randomized Trial Traumatic Injury Protocol


Type Source Name
drug DRUGBANK Dronabinol
drug DRUGBANK Medical Cannabis
drug DRUGBANK Morphine
drug DRUGBANK Coenzyme M
disease MESH chronic pain
disease MESH multiple sclerosis
disease MESH sleep
disease MESH sleep apnea
disease MESH fibromyalgia
drug DRUGBANK Insulin Aspart
disease MESH marijuana use
disease MESH Diagnosis
disease MESH allergy
drug DRUGBANK Sesame oil
disease MESH complications
drug DRUGBANK Methionine
drug DRUGBANK Etoperidone
disease MESH death
disease MESH Respiratory depression
disease MESH hypoxia
disease MESH Hypotension
disease MESH Urinary retention
disease MESH ileus
disease MESH Somnolence
disease MESH Delirium
drug DRUGBANK Aspartame
disease MESH cognitive impairment
drug DRUGBANK Ethanol
drug DRUGBANK Cannabidiol
disease MESH neurologic disorders
drug DRUGBANK Naloxone
disease MESH alcohol abuse
drug DRUGBANK Fentanyl


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