Cannabis for Spasticity in Multiple Sclerosis
Information source: University of California, Davis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Smoked Cannabis (Drug); Smoked Cannabis and oral marinol (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: University of California, Davis Official(s) and/or principal investigator(s):
Mark Agius, MD, Principal Investigator, Affiliation: University of California, Davis
Overall contact:
Janelle Butters, R.N., Phone: 916-734-6276, Email: janelle.butters@ucdmc.ucdavis.edu
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.
Clinical Details
Official title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in an objective measurement of spasticity between the pretreatment assessment and the 3- and 7-week assessments
Secondary outcome: 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.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- 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
- 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
Locations and Contacts
Janelle Butters, R.N., Phone: 916-734-6276, Email: janelle.butters@ucdmc.ucdavis.edu
University of California Davis Medical Center, Sacramento, California 95817, United States; Recruiting
Mark Agius, M.D., Principal Investigator
Additional Information
Starting date: March 2003
Ending date: January 2010
Last updated: May 22, 2008
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