| Trial ID | NCT06454669 |
| Phase | N/A |
| Status | Recruiting |
| Condition | Low Back Pain |
| Intervention | Dronabinol |
Chronic low back pain affects millions globally with limited effective treatment options, and this represents one of the first rigorous placebo-controlled trials specifically examining synthetic THC for this indication. The study addresses a critical evidence gap in cannabinoid medicine where most chronic pain data comes from observational studies rather than controlled trials.
This is an exploratory proof-of-concept, double-blind, placebo-controlled trial randomizing up to 75 participants with chronic low back pain 2:1 to receive oral dronabinol (synthetic THC) up to 30mg daily versus placebo over 8 weeks. The primary focus is establishing safety profiles and feasibility rather than efficacy endpoints, with results intended to inform the design of future larger-scale trials. The study is currently recruiting participants at a single site.
“If this trial demonstrates acceptable safety and tolerability profiles, it could provide the foundational data needed to advance synthetic THC into larger efficacy trials for chronic low back pain. This represents an important step toward evidence-based cannabinoid prescribing for one of the most common pain conditions I encounter in practice.”
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FAQ
What is dronabinol, and how is it being tested in this trial?
Dronabinol is synthetic THC. In this trial, people with chronic low back pain take oral dronabinol at doses up to 30 mg daily, or a placebo, over 8 weeks, and the two groups are compared.
How many people will be enrolled, and how are they assigned?
The trial plans to randomize up to 75 participants with chronic low back pain in a 2:1 ratio, so about two participants receive dronabinol for every one who receives placebo. It is an exploratory proof-of-concept study with a double-blind, placebo-controlled design.
Is this trial designed to prove that dronabinol relieves back pain?
No. Its primary focus is establishing safety profiles and feasibility rather than efficacy endpoints. The results are intended to inform the design of future, larger trials, so this study is not built to show definitively whether dronabinol reduces low back pain.
Is the dronabinol back pain trial currently enrolling participants?
Yes. The trial, registered as NCT06454669, is listed as recruiting, with participants being enrolled at a single site. The summary does not describe eligibility criteria beyond chronic low back pain, and it does not name the site location.
