Smoked Cannabis in Multiple Sclerosis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Intervention / Treatment

Drug: Smoked Cannabis

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 Type

Interventional

Enrollment

30

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92093
    - UC San Diego Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Medicinal Cannabis Research

Investigators

Principal Investigator: Jody Corey-Bloom, M.D., Ph.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Center for Medicinal Cannabis Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria