Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis

NCT00248378 | Completed Phase 1

• 2 other identifiers: C00-SD-103030002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cannabis; Spasticity; Tolerability

Outcome Measures

Primary Outcomes (1)

• Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test

Secondary Outcomes (2)

• Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale

• Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory

Interventions

Smoked Cannabis DRUG

Eligibility Criteria

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

You may qualify if:

• Clinically definite or probable, laboratory-supported MS
• Complaints of spasticity and at least moderate increase in tone as evidenced by a score of \>= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee
• If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months
• Fluent in English
• If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
• If on either lioresal (Baclofen) or tizanadine (Zanaflex), have been on a stable dose for at least three months
• \>=18 years of age

You may not qualify if:

• Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI
• Recent history of active substance abuse defined as daily use for at least 14 days within the past month
• Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
• Any unstable medical health problem
• Any known pulmonary disorders, including tuberculosis, asthma, or COPD
• Pregnant or nursing
• Require benzodiazepines to control spasticity
• Require high doses of analgesic medications on a daily basis

Sponsors & Collaborators

• Center for Medicinal Cannabis Research: lead

Study Sites (1)

UC San Diego Medical Center

San Diego, California, 92093, 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

• Jody Corey-Bloom, M.D., Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: September 1, 2001
• Study Completion: March 1, 2005
• Last Updated: June 23, 2006

Record last verified: 2006-06

Locations

US (1)