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Cannabis for Spasticity in Multiple Sclerosis

This study is currently recruiting participants.
Verified July 2012 by University of California, Davis
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00682929
First received: May 19, 2008
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  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
Drug: Smoked Cannabis and oral marinol
Drug: Placebo
 Phase 1
Phase 2

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

Resource links provided by NLM:

Drug Information available for: Dronabinol
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in an objective measurement of spasticity between the pretreatment assessment and the 3- and 7-week assessments [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2003
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1)
Inhaled cannabis is compared to oral placebo.
 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.
Other Name: Cannabis
Active Comparator: 2
Inhaled placebo and oral THC.
 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.
Other Name: dronabinol
Placebo Comparator: 3
Inhaled placebo is compared to oral placebo.
 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.
Other Name: placebo

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
  • Moderate or severe spasticity
  • Age 21 or older
  • Must live close to the Sacramento, CA area

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682929

Contacts
Contact: Janelle Butters, R.N. 916-734-6276 janelle.butters@ucdmc.ucdavis.edu

Locations
United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Mark Agius, M.D.            
Sponsors and Collaborators
University of California, Davis
National Multiple Sclerosis Society
Investigators
Principal Investigator: Mark Agius, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00682929     History of Changes
Other Study ID Numbers: 200311404, MS Society Award # RG 3781-A-1
Study First Received: May 19, 2008
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
cannabis
marijuana
Multiple Sclerosis
spasticity

Additional relevant MeSH terms:
Marijuana Abuse
Multiple Sclerosis
Muscle Spasticity
Sclerosis
Substance-Related Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
 Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013