Cannabis for Spasticity in 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

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

Inclusion Criteria:

- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria

- Moderate or severe spasticity

- Age 21 or older

- Must live close to the Sacramento, CA area

Exclusion Criteria:

- Preexisting pulmonary conditions, including poorly controlled asthma, chronic
bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders

- Preexisting cardiac conditions, including ischemic heart disease, congestive heart
failure, and other significant cardiac disorders

- Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative
or hypnotic medications during the duration of the study

- Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled
psychiatric illness

- Past history of abuse of recreational drugs, including marijuana and alcohol in the
last 12 months

- History of or currently meets DSM-IV criteria for dependence on cannabis

- Use of cannabis, marijuana, or THC in the last four weeks

- Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled
psychiatric illness

- Exacerbation of MS within 30 days prior to screening visit

- Current use of cyclophosphamide, mitoxantrone, or cladribine

- Arthritis, bony and soft tissue disorders interfering with spasticity measures

- Inability to provide informed consent

- Recent cannabis use of more than twice per week one month prior to study entry

- For females of child bearing potential, inability to comply with adequate
contraception