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

This study has been completed.
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00248378
First received: November 2, 2005
Last updated: June 21, 2006
Last verified: June 2006
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Smoked Cannabis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: September 2001
Estimated Study Completion Date: March 2005
Detailed Description:

Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.

The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).

Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248378

Locations
United States, California
UC San Diego Medical Center
San Diego, California, United States, 92093
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Jody Corey-Bloom, M.D., Ph.D. University of California, San Diego
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00248378     History of Changes
Other Study ID Numbers: C00-SD-103, 030002
Study First Received: November 2, 2005
Last Updated: June 21, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
Multiple Sclerosis
Cannabis
Spasticity
Tolerability

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014