Cannabis for Spasticity in Multiple Sclerosis

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Smoked Cannabis

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring cannabis, marijuana, Multiple Sclerosis, Spasticity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria Primary or secondary disease course Moderate or severe spasticity Age 21 or older Exclusion Criteria: Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months History of or currently meets DSM-IV criteria for dependence on cannabis Use of cannabis, marijuana, or THC in the last two weeks Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness Exacerbation of MS within 30 days prior to screenin visit Current use of cyclophosphamide, mitoxanthrone, or cladribine Arthritis, bony and soft tissue disorders interfering with spasticity measures Inability to provide informed consent Recent cannabis use of more than twice per week one month prior to study entry

Sites / Locations

UC Davis Medical Center

Outcomes

Primary Outcome Measures

Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.

Secondary Outcome Measures

Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.

Full Information

NCT ID

NCT00260741

First Posted

November 30, 2005

Last Updated

April 3, 2007

Sponsor

Center for Medicinal Cannabis Research

1. Study Identification

Unique Protocol Identification Number

NCT00260741

Brief Title

Cannabis for Spasticity in Multiple Sclerosis

Official Title

Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Terminated

Why Stopped

Discontinued due to non-enrollment.

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Center for Medicinal Cannabis Research

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.

Detailed Description

The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present. Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease. Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

cannabis, marijuana, Multiple Sclerosis, Spasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Smoked Cannabis

Primary Outcome Measure Information:

Title

Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.

Secondary Outcome Measure Information:

Title

Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria Primary or secondary disease course Moderate or severe spasticity Age 21 or older Exclusion Criteria: Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months History of or currently meets DSM-IV criteria for dependence on cannabis Use of cannabis, marijuana, or THC in the last two weeks Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness Exacerbation of MS within 30 days prior to screenin visit Current use of cyclophosphamide, mitoxanthrone, or cladribine Arthritis, bony and soft tissue disorders interfering with spasticity measures Inability to provide informed consent Recent cannabis use of more than twice per week one month prior to study entry

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Agius, M.D.

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cmcr.ucsd.edu

Description

Center for Medicinal Cannabis Research

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial