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Cannabis for Spasticity in Multiple Sclerosis

This study has been terminated.
(Unable to complete subject recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682929
First Posted: May 23, 2008
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of California, Davis
  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: Inhaled Cannabis Drug: Oral THC Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 University of California, Davis:

Primary Outcome Measures:
  • LITO Machine Score [ Time Frame: 7 weeks ]
    Numerical score, Change in an objective measurement of spasticity between the pretreatment assessment and the 3- and 7-week assessments


Secondary Outcome Measures:
  • Ashworth Scale [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo

  • Functional System Score [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo

  • Expanded Disability Status Score [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo

  • Ambulation Index [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo

  • Quality of Life Inventory [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo

  • Functional Composite Score [ Time Frame: 7 weeks ]
    Measuring numerical score differences between active agent (cannabis) and placebo


Enrollment: 42
Study Start Date: November 2003
Estimated Study Completion Date: September 2018
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) Inhaled Cannabis
Inhaled cannabis is compared to oral placebo.
Drug: Inhaled 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) Oral THC
Inhaled placebo is compared to oral THC.
Drug: Oral THC
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) Placebo
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00682929


Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Multiple Sclerosis Society
Investigators
Principal Investigator: Michelle Apperson, MD, PhD University of California, Davis
  More Information

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 ( Other Grant/Funding Number: MS Society )
First Submitted: May 19, 2008
First Posted: May 23, 2008
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
Marijuana Abuse
Pathologic Processes
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
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators