Status:
COMPLETED
Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
Lead Sponsor:
Center for Medicinal Cannabis Research
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.
Detailed Description
Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Rec...
Eligibility Criteria
Inclusion
- Clinically definite or probable, laboratory-supported MS
- Complaints of spasticity and at least moderate increase in tone as evidenced by a score of \>= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee
- If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months
- Fluent in English
- If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
- If on either lioresal (Baclofen) or tizanadine (Zanaflex), have been on a stable dose for at least three months
- \>=18 years of age
Exclusion
- Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI
- Recent history of active substance abuse defined as daily use for at least 14 days within the past month
- Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
- Any unstable medical health problem
- Any known pulmonary disorders, including tuberculosis, asthma, or COPD
- Pregnant or nursing
- Require benzodiazepines to control spasticity
- Require high doses of analgesic medications on a daily basis
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00248378
Start Date
September 1 2001
End Date
March 1 2005
Last Update
June 23 2006
Active Locations (1)
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1
UC San Diego Medical Center
San Diego, California, United States, 92093