A Randomized, Cross-Over Controlled Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain

INVESTIGATORS: Barth Wilsey, M.D. & Thomas Marcotte, Ph.D.

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: A Randomized, Cross-Over Controlled Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain

PROJECT TYPE: Clinical Study

STATUS: ACTIVE

ABSTRACT:

This study will involve treating low back pain associated with nerve injury with oral delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.5% Δ9-THC, or placebo. The major objective of the present study is to demonstrate an analgesic response to oral and/or inhaled cannabis in patients with neuropathic low back pain.

The primary outcome will be a pain intensity numerical rating scale bordered by 0=no pain and 10=worst possible pain. As a major goal in the development of cannabinoid-based medications is the separation of pain relief from side-effects, numerous other assessments will also be performed. Neuropsychological testing with the Digit Symbol Modalities Test (attention), the Hopkins Verbal Learning Test (learning and memory) and the Grooved Pegboard Test (psychomotor performance) will be performed. In addition, driving simulation will be completed to assess the effect of study medications on this important component of everyday life. Subjective effects will be evaluated with the Marijuana subscale (M-scale) from the Addiction Research Center Inventory to evaluate cannabis intoxication. In addition, questions that include measures of 'high' or 'liking' will be analyzed.

The degree of pain relief will then be compared with the adverse consequences of cannabis to assess the risk-benefit ratio of dronabinol and 3.5% Δ9-THC.

 

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Igor Grant, MD

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Daniele Piomelli, MD, PhD, PharmD

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