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Cannabis for Spasticity in Multiple Sclerosis

This study has been terminated.
(Discontinued due to non-enrollment.)
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00260741
First received: November 30, 2005
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

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
Multiple Sclerosis
Drug: Smoked Cannabis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:
  • Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.

Secondary Outcome Measures:
  • Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.

Estimated Enrollment: 60
Study Start Date: March 2003
Study Completion Date: January 2006
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 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: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260741

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Mark Agius, M.D. University of California, Davis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260741     History of Changes
Other Study ID Numbers: C00-DA-112, 200311404-4
Study First Received: November 30, 2005
Last Updated: April 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
cannabis
marijuana
Multiple Sclerosis
Spasticity

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Muscle Spasticity
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014