A Randomized, Double-Blind, Placebo-Controlled Study to Explore Safety and Potential Pain Relief of Dronabinol in Adults with Chronic Low Back Pain

What this Trial Is About

Researchers are evaluating the safety and potential pain-reducing effects of dronabinol, a synthetic form of THC, in adults with chronic low back pain. This exploratory, double-blind, placebo-controlled, randomized study aims to gather early evidence on whether dronabinol is safe enough to justify larger clinical trials. The study focuses on chronic low back pain lasting at least three months and occurring frequently over the past six months. Participants will be randomly assigned in a 2:1 ratio to receive either dronabinol capsules or matching placebo capsules twice daily for eight weeks. The dronabinol dose starts at 2.5 mg twice on the first day and may be gradually increased up to 30 mg per day as tolerated. Placebo participants will undergo a similar dosing schedule to maintain blinding. This single-site study does not include interim analyses or stratifications. During the study, participants will be monitored for pain intensity and adverse events from baseline through eight weeks. Researchers will also track analgesic use, mood, and patient-reported outcomes using questionnaires. Safety assessments include regular clinical evaluations and laboratory tests. Participants must remain on stable opioid regimens if applicable and avoid adding new pain medications. The total participation duration is eight weeks, with close observation throughout the study period.

Dronabinol as an Adjunct for Reducing Pain