Cannabis for Spasticity in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260741
Recruitment Status : Terminated (Discontinued due to non-enrollment.)
First Posted : December 2, 2005
Last Update Posted : April 4, 2007
Information provided by:
Center for Medicinal Cannabis Research

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Smoked Cannabis Phase 1 Phase 2

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, with the effects of these agents analyzed at thirty and sixty days.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
Study Start Date : March 2003
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.

Secondary Outcome Measures :
  1. Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00260741

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Principal Investigator: Mark Agius, M.D. University of California, Davis

Additional Information: Identifier: NCT00260741     History of Changes
Other Study ID Numbers: C00-DA-112
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

Keywords provided by Center for Medicinal Cannabis Research:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Marijuana Abuse
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders