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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Medicinal Cannabis Research

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