Condition: Low Back Pain · Chronic Pain · Back Injuries · Sponsor: Christopher D. Verrico
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
This description comes directly from the study's public registry record.
Christopher D Verrico, PhD · 713-791-1414 · verrico@bcm.edu
Adetola O Vaughan, MA · 713-791-1414 · avaughan@bcm.edu
Always discuss trial participation with your own doctor first.
| Michael E Debakey VA Medical Center | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06454669