Conditions: Multiple Sclerosis
Keywords: cannabis marijuana Multiple Sclerosis spasticity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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

The effects of these agents analyzed at 3 weeks and 7 weeks.

Arms:
arm 1: Inhaled cannabis is compared to oral placebo. arm 2: Inhaled placebo is compared to oral THC. arm 3: Inhaled placebo is compared to oral placebo.

Interventions: intervention 1: Inhaled Cannabis intervention 2: Oral THC intervention 3: Oral Placebo intervention 4: Inhaled placebo
Intervention descriptions: intervention 1: Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks. intervention 2: Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks. intervention 3: Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks. intervention 4: Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.

Protocol document: