Oral Synthetic Tetrahydrocannabinol (osTHC) was safe but not effective at reducing opioid consumption after 1-3 level lumbar fusions: A double-blind, randomized, controlled trial
Attending Surgeon Norton Leatherman Spine Center Princeton University Louisville, KY, US
Disclosure(s):
Jeffrey L. Gum, MD: No relevant disclosure to display
Introduction: Given the opioid epidemic, there is a need to minimize opioid exposure to avoid side-effects and long-term dependence. Recent studies have investigated orally administered synthetic active form of delta-9-THC to minimize opioid consumption in non-spine, orthopedic procedures with some success. The objective of this prospective double blind randomized clinical trial was evaluate the safety and potential efficacy of osTHC to reduce opioid consumption following 1- to 3-level lumbar fusion.
Methods: Patients scheduled for 1-3 level lumbar instrumented fusion for degenerative conditions were enrolled. Patients with depression, anxiety, or previous drug use disorder were excluded. State law did not allow assessment of pre-operative THC use. The treatment arm received 5mg of THC immediately prior to surgery and 5mg every 12 hours postoperatively for 96 hours. The placebo arm received a similar appearing capsule. A standardized opioid escalation protocol was utilized postoperatively and daily opioid consumption was collected. Patients and care team were blinded to treatment arm.
Results: Sixty-three patients were offered study participation, with 39 (62%) being randomized. Failure to enroll resulted from secondary screening failure (14), cancellations (4), and refusal (7). There were no differences in demographics, preoperative, or operative parameters between groups. Post-operative opioid use was similar in in the THC and placebo groups. Post-operative complications were also equal in the two groups.
Conclusion : Low dose oral synthetic THC was safe, but not effective in reducing post-operative opioid use. Excluding patients with depression, anxiety, or prior drug use may have eliminated a population that would have benefitted from treatment. Pre-existing THC consumption might influence the effectiveness of an oral 5mg dose twice daily, and despite randomization, the study was small enough that a confounding effect might persist. Under the current study parameters, an osTHC is not effective in reducing opioid consumption, but does appear safe. Future efforts should consider patient specific dosing.