Cannabis for Spasticity in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of California, Davis.
Recruitment status was  Recruiting
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

May 19, 2008
July 5, 2012
March 2003
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00682929 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Cannabis for Spasticity in Multiple Sclerosis
Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • 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
  • 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
  • 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
  • Active Comparator: 1)
    Inhaled cannabis is compared to oral placebo.
    Intervention: Drug: Smoked Cannabis
  • Active Comparator: 2
    Inhaled placebo and oral THC.
    Intervention: Drug: Smoked Cannabis and oral marinol
  • Placebo Comparator: 3
    Inhaled placebo is compared to oral placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Janelle Butters, R.N. 916-734-6276 janelle.butters@ucdmc.ucdavis.edu
United States
 
NCT00682929
200311404, MS Society Award # RG 3781-A-1
Yes
University of California, Davis
University of California, Davis
National Multiple Sclerosis Society
Principal Investigator: Mark Agius, MD University of California, Davis
University of California, Davis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP