Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898974
• Other study ID #: 16-6685HH
• Status: Completed
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2019
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.

Description:

To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Medically diagnosed with MS,

• 30-60 years of age,

• Moderate disability (Patient Determined Disease Steps score 2-6).

Exclusion Criteria:

• Relapse with the last 60 days,

• High risk for cardiovascular disease (American College of Sports Medicine risk classification),

• Changes in disease modifying medications within the last 45 days,

• Concurrent neurological/neuromuscular disease,

• Hospitalization within the last 90 days,

• Inability to understand/sign informed consent.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Medical Marijuana
To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design

Locations

Country	Name	City	State
United States	Department of Health and Exercise Science	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	William R. Shaffer, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Strength decline during fatiguing muscle contraction measured with force transducer	Through study completion, an average of 6 months.
Primary	Muscle Strength	Maximal muscle strength measured with force transducer	Through study completion, an average of 6 months.
Primary	Postural Stability	Timed up and go	Through study completion, an average of 6 months.