Cannabis for Spasticity in Multiple Sclerosis

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00260741

Run by

Center for Medicinal Cannabis Research

People needed

60

Starts

2003-03-01

Expected to finish

2006-01-01

Last updated by the study team

2007-04-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
• Primary or secondary disease course
• Moderate or severe spasticity
• Age 21 or older

You may not qualify if…

• 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
• 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 two weeks
• Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
• Exacerbation of MS within 30 days prior to screenin visit
• Current use of cyclophosphamide, mitoxanthrone, 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

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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