Status:
TERMINATED
Cannabis for Spasticity in Multiple Sclerosis
Lead Sponsor:
Center for Medicinal Cannabis Research
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
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 ...
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 agent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00260741
Start Date
March 1 2003
End Date
January 1 2006
Last Update
April 4 2007
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817