Cannabis for Spasticity in Multiple Sclerosis

University of California (UC) Davis

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Inhaled placebo; Drug: Oral THC; Drug: Inhaled Cannabis; Drug: Oral Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00682929

251429

MS Society Award # RG 3781-A-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 3 patient groups, including a placebo group

1) Inhaled Cannabis

Active Comparator group

Description:

Inhaled cannabis is compared to oral placebo.

Treatment:

Drug: Oral Placebo

Drug: Inhaled Cannabis

2) Oral THC

Active Comparator group

Description:

Inhaled placebo is compared to oral THC.

Treatment:

Drug: Oral THC

Drug: Inhaled placebo

3) Placebo

Placebo Comparator group

Description:

Inhaled placebo is compared to oral placebo.

Treatment:

Drug: Oral Placebo

Drug: Inhaled placebo