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

Sponsor

Center for Medicinal Cannabis Research (Other)

Overall Status

Completed

CT.gov ID

NCT00248378

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Smoked Cannabis	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2001

Study Completion Date :

Mar 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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