Testing THC's potential as a safer pain treatment for Veterans

Chronic low back pain is common, disabling, and often inadequately controlled with current pharmacologic options, underscoring the need for safer non-opioid treatments. Dronabinol, a synthetic formulation of Δ9-tetrahydrocannabinol, has analgesic potential but has not been rigorously evaluated for chronic low back pain. This article describes a phase IIa, single-site, randomized, double-blind, placebo-controlled, parallel-group trial in Veterans with chronic low back pain. Seventy-five participants will be randomized 2:1 to oral dronabinol or matching placebo for 8 weeks following a screening period of up to 4 weeks. The primary objective is to evaluate safety and tolerability. Primary outcomes include treatment-emergent adverse events, serious adverse events, laboratory findings, vital signs, and electrocardiogram results. Secondary outcomes are exploratory and include pain intensity, physical functioning, emotional functioning, global improvement, analgesic use, and medication adherence. This study is designed to generate safety data and preliminary estimates of variance and effect size to inform a future confirmatory trial; it is not powered to test efficacy hypotheses.Clinical trial registration: http://www.clinicaltrials.gov identifier is NCT06454669. Chronic low back pain is common, can last for years, and can make everyday life much harder. Many people continue to have pain even after trying available treatments. Opioid pain medicines can help some patients, but they also have important risks, including dependence, overdose, and other serious side effects. Because of this, safer non-opioid treatment options are needed. Dronabinol is a prescription form of tetrahydrocannabinol (THC), a compound related to cannabis. It is already approved in the United States for other medical uses, but it has not been well studied for chronic low back pain. This article describes the plan for a clinical trial in Veterans with chronic low back pain. The main goal of the study is to learn whether dronabinol can be given safely and tolerated over 8 weeks. The study will also collect early information on whether dronabinol may affect pain, daily functioning, mood, and use of other pain medicines. These additional results are exploratory, which means the study is not large enough to prove that the treatment works. In this trial, 75 participants will be assigned by chance to receive either dronabinol or placebo. The study is double-blind, so neither participants nor study staff will know which treatment each participant receives during the trial. The results will help researchers decide whether a larger future study should be done.