Cannabis for Spasticity in Multiple Sclerosis - Full Text View

Sponsor:	University of California, Davis
Collaborator:	National Multiple Sclerosis Society
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00682929

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 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

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Multiple Sclerosis

Drug Information available for: GW-1000 Tetrahydrocannabinol Cannabis

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:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1): Active Comparator 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.
2: Active Comparator 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.
3: Placebo Comparator 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:

inhaled cannabis and oral placebo
inhaled placebo and oral THC
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

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 ( 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:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00682929 History of Changes
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:

Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Signs and Symptoms
Multiple Sclerosis
Pathologic Processes
Musculoskeletal Diseases
Sensory System Agents
Muscle Hypertonia
Therapeutic Uses
Analgesics
Autoimmune Diseases of the Nervous System
Neuromuscular Manifestations
Autoimmune Diseases

Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Sclerosis
Pharmacologic Actions
Tetrahydrocannabinol
Muscle Spasticity
Muscular Diseases
Analgesics, Non-Narcotic
Demyelinating Autoimmune Diseases, CNS
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010