INVESTIGATOR: Mark Agius, M.D.
STUDY LOCATION: University of California, Davis
PROJECT TITLE: Cannabis for Spasticity/Tremor in MS: Placebo Controlled Study
PROJECT TYPE: Clinical Study
STATUS: FUNDING DISCONTINUED
This study sought to evaluate the safety and efficacy of smoked cannabis in relieving the spasticity associated with multiple sclerosis (MS) as measured by a new objective measure of spasticity. Unfortunately, recruitment for this study proved to be difficult for many reasons, including a prohibition on driving throughout the 16 weeks participants were enrolled in the study. The study was reviewed by the CMCR Scientific Review Board and Data Safety Monitoring Board who both recommended discontinuation for lack of feasibility. No preliminary analyses of safety or efficacy were possible.
The goal of this proposal is to rigorously assess the efficacy and safety of marijuana (cannabis) smoking and the efficacy and safety of the oral cannabinoid delta-5-tetrahydrocannabinol (THC) in the treatment of spasticity in secondary-progressive multiple sclerosis (MS). Anecdotal reports and a small controlled study have reported improved spasticity, and to some extent improved tremor, in MS patients. A recent carefully controlled study of the efficacy of THC in experimental allergic encephalomyelitis, the animal model of MS, demonstrated significant amelioration of these symptoms. In addition the lay community has actively advocated the use of these agents to the extent of the recent passage of a number of state laws permitting the medicinal use of marijuana in this, and other, diseases. Many studies of the pharmacology of THC have identified effects on motor systems of the central nervous system that have the potential of affecting these two symptoms. Moreover, THC has demonstrated effects on immune function that also have the potential of reducing the autoimmune attack that is thought to be the underlying pathogenic process in MS.
We will carry out a randomized, placebo-controlled double-blinded trial of daily inhaled cannabis vs. placebo and daily oral THC vs. placebo. The trial, which is also designed to compare inhaled cannabis to oral THC by using both oral and inhaled agents "simultaneously" in each patient, will involve three treatment arms of 20 patients each: inhaled cannabis and oral placebo, inhaled placebo and oral THC, and inhaled placebo and oral placebo. The primary endpoint for spasticity will be a quantitative physiologic measure of active resistance to movement, whereas the secondary endpoints will be standard ordinal measures of functionality in MS patients.