Cannabis for Spasticity in Multiple Sclerosis
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00682929
- Run by
- University of California, Davis
- People needed
- 41
- Starts
- 2004-04-14
- Expected to finish
- 2011-08-17
- Last updated by the study team
- 2018-05-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California Davis Medical Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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