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Sponsors and Collaborators: |
University of California, Davis National Multiple Sclerosis Society |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00682929 |
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.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Smoked Cannabis Drug: Smoked Cannabis and oral marinol Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study |
Estimated Enrollment: | 60 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1): Active Comparator
Inhaled cannabis is compared to oral placebo.
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Drug: Smoked Cannabis
20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.
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2: Active Comparator
Inhaled placebo and oral THC.
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Drug: Smoked Cannabis and oral marinol
20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.
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3: Placebo Comparator
Inhaled placebo is compared to oral placebo.
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Drug: Placebo
20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
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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:
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janelle Butters, R.N. | 916-734-6276 | janelle.butters@ucdmc.ucdavis.edu |
United States, California | |
University of California Davis Medical Center | Recruiting |
Sacramento, California, United States, 95817 | |
Principal Investigator: Mark Agius, M.D. |
Principal Investigator: | Mark Agius, MD | University of California, Davis |
Responsible Party: | University of California, Davis ( Mark Agius, M.D., Principal Investigator ) |
Study ID Numbers: | 200311404, MS Society Award # RG 3781-A-1 |
Study First Received: | May 19, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00682929 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
cannabis marijuana Multiple Sclerosis spasticity |
Tetrahydrocannabinol Muscle Spasticity Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Marijuana Abuse Autoimmune Diseases of the Nervous System |
Immune System Diseases Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Pharmacologic Actions Pathologic Processes |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |