Cannabis for Spasticity in Multiple Sclerosis

• Status: Terminated
• Trial end date: 2011-08-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: National Multiple Sclerosis Society
• Treatments: Dronabinol

Criteria

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