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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248378
• Other study ID #: C00-SD-103
• Secondary ID: 030002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 2, 2005
• Last updated: June 21, 2006
• Start date: September 2001
• Est. completion date: March 2005

Study information

• Verified date: June 2006
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

Drug:
• Smoked Cannabis

Locations

Country	Name	City	State
United States	UC San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
Secondary	Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
Secondary	Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory

External Links

•   Center for Medicinal Cannabis Research