Trial Outcomes & Findings for Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis (NCT NCT02898974)

Results Overview

Strength decline during fatiguing muscle contraction measured with force transducer

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

Through study completion, an average of 6 months.

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Regular Medical Marijuana Users People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design	Non Users of Medical Marijuana People with MS that are non users of Medical Marijuana
Overall Study STARTED	13	9
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regular Medical Marijuana Users n=13 Participants People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design	Non Users of Medical Marijuana n=9 Participants People with MS that are non users of Medical Marijuana	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=9 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=13 Participants	7 Participants n=9 Participants	18 Participants n=22 Participants
Age, Categorical >=65 years	2 Participants n=13 Participants	2 Participants n=9 Participants	4 Participants n=22 Participants
Sex: Female, Male Female	9 Participants n=13 Participants	6 Participants n=9 Participants	15 Participants n=22 Participants
Sex: Female, Male Male	4 Participants n=13 Participants	3 Participants n=9 Participants	7 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	9 participants n=9 Participants	22 participants n=22 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 6 months.

Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. Matching was only possible for 16 subjects. The remaining 6 subjects were not included in the analysis.

Strength decline during fatiguing muscle contraction measured with force transducer

Outcome measures

Outcome measures
Measure	Regular Medical Marijuana Users n=8 Participants People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design	Non Users of Medical Marijuana n=8 Participants People with MS that are non users of Medical Marijuana
Fatigue	21 % decline Standard Deviation 13	24 % decline Standard Deviation 15

PRIMARY outcome

Timeframe: Through study completion, an average of 6 months.

Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.

Maximal muscle strength measured with force transducer

Outcome measures

Outcome measures
Measure	Regular Medical Marijuana Users n=8 Participants People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design	Non Users of Medical Marijuana n=8 Participants People with MS that are non users of Medical Marijuana
Muscle Strength	28.7 Newton Standard Deviation 7.7	33.6 Newton Standard Deviation 10.1

PRIMARY outcome

Timeframe: Through study completion, an average of 6 months.

Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.

Timed up and go

Outcome measures

Outcome measures
Measure	Regular Medical Marijuana Users n=8 Participants People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design	Non Users of Medical Marijuana n=8 Participants People with MS that are non users of Medical Marijuana
Postural Stability	9.2 Seconds Standard Deviation 3.4	11.5 Seconds Standard Deviation 13.5

Adverse Events

Regular Medical Marijuana Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Users of Medical Marijuana

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager of Research Operations

Colorado State University

Phone: 9704912242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place