Multiple Sclerosis Clinical Trial
Official title:
Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids
seem to reduce the duration of attacks and to reduce the likelihood of future attacks.
Immunomodulatory agents, available in this disease over the last decade, reduce the
frequency of severe attacks by about one third. The remainder of the treatments are
symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may
have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In
light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune
function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2)
inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these
agents analyzed at thirty and sixty days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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