Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00248378 |
Recruitment Status :
Completed
First Posted : November 4, 2005
Last Update Posted : June 23, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Smoked Cannabis | Phase 1 Phase 2 |
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. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.
The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).
Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis |
Study Start Date : | September 2001 |
Study Completion Date : | March 2005 |

- Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
- Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
- Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

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 ClinicalTrials.gov identifier (NCT number): NCT00248378
United States, California | |
UC San Diego Medical Center | |
San Diego, California, United States, 92093 |
Principal Investigator: | Jody Corey-Bloom, M.D., Ph.D. | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00248378 |
Other Study ID Numbers: |
C00-SD-103 030002 |
First Posted: | November 4, 2005 Key Record Dates |
Last Update Posted: | June 23, 2006 |
Last Verified: | June 2006 |
Multiple Sclerosis Cannabis Spasticity Tolerability |
Muscle Spasticity Multiple Sclerosis Sclerosis Marijuana Abuse Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |