Cannabis for Spasticity in Multiple Sclerosis

NCT00260741 | Terminated Phase 1

• 2 other identifiers: C00-DA-112200311404-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

cannabis; marijuana; Multiple Sclerosis; Spasticity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Smoked Cannabis DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
• Primary or secondary disease course
• Moderate or severe spasticity
• Age 21 or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Medicinal Cannabis Research: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

• Center for Medicinal Cannabis Research

MeSH Terms

Conditions

Multiple Sclerosis; Marijuana Abuse; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Agius, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 2, 2005
• Study Start: March 1, 2003
• Study Completion: January 1, 2006
• Last Updated: April 4, 2007

Record last verified: 2007-04

Locations

US (1)