The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Did not pursue study
What was tested
Treatment tested
- Dronabinol
Cannabinoid CB1 receptor agonist
Placebo or sham
- Placebo
What it measured
Main measures
Leg Strength
1 year
Physical functionFatigue Severity Scale
1 year
Fatigue25 foot walk test
1 year
Walking and mobility9 hole peg test
1 year
Disability progressionPaced Auditory Serial Addition Test
1 year
Becks Depression Inventory
1 year
Mood and sleepQuality of Life
1 year
Quality of life (reported by participants)Pain Effect Scale.
1 year
Pain
Other measures (2)
Fat Mass
1 year
Physical functionLean Body Mass
1 year
Who could take part
MS (type not specified) · 21 to 74
Inclusion Criteria: * Medically diagnosed with MS * Age range 21-74 years of age * Moderate disability (Patient Determined Disease Steps score 2-6) * All participants must have a medical (red) card for medical marijuana use to treat their MS symptoms (such as neuropathic pain and spasticity), or currently be in the process of applying for a red card and be able to provide the prescription from their doctor. Exclusion Criteria: * Previous use of marijuana * A relapse of disease symptoms in the last 60 days * A condition unrelated to MS that would exacerbate fatigue, such as anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder * Medical diagnosis or condition that makes participating in exercise training dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders * History of heart attack or current diagnosis of cardiovascular disease * History of seizure disorders (or on medications known to lower seizure threshold), hydrocephalus (buildup of fluid in the brain), or diabetes * Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug abuse * History of significant traumatic brain injury or hydrocephalus * Pregnancy * Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state * Current participation in another research study that involves experiments on drugs or interventions which may influence motor and cognitive function.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Over the last two years, the United States has witnessed enormous change concerning the acceptance of marijuana. The number of persons with MS (PwMS) using cannabis to treat their symptoms is expected to rise, and it is important to provide clinicians and PwMS with evidence based information on the safety and effectiveness of marijuana. In addition, scientists need to identify the effects of medical marijuana as the compound action of different cannabinoids, specifically tetrahydrocannabinol (THC) and cannabidiol (CBD). The ratio of CBD to THC may have an important impact on the effects of the marijuana, which in turn may have important implications for the medical benefits. The overarching goal of this study is to advance a better understanding of the potential positive and negative effects associated with different strains of marijuana, using an interventional design. The investigators will examine three strains that differ markedly on THC potency (A. THC \<1%, CBD > 10%; B. THC >10%, CBD \< 1%; C. THC 510%, CBD 510%) to determine whether the level of THC is associated with differences in motor and cognitive functions in PwMS. One hundred PwMS will be recruited for this project and followed for 3 months following designation to one of three strains of marijuana with different ratios of CBD to THC or a placebo marijuana (THC 0%, CBD 0%). It is hypothesized that the strains with a high CBD to THC ratios will demonstrate the most benefits on measures of motor and cognitive function.
Papers
Background
Etemadi Y. Dual task cost of cognition is related to fall risk in patients with multiple sclerosis: a prospective study. Clin Rehabil. 2017 Feb;31(2):278-284. doi: 10.1177/0269215516637201. Epub 2016 Jul 10.Background
Ghanavati T, Salavati M, Karimi N, Negahban H, Ebrahimi Takamjani I, Mehravar M, Hessam M. Intra-limb coordination while walking is affected by cognitive load and walking speed. J Biomech. 2014 Jul 18;47(10):2300-5. doi: 10.1016/j.jbiomech.2014.04.038. Epub 2014 May 9.Background
Hart CL, Ilan AB, Gevins A, Gunderson EW, Role K, Colley J, Foltin RW. Neurophysiological and cognitive effects of smoked marijuana in frequent users. Pharmacol Biochem Behav. 2010 Sep;96(3):333-41. doi: 10.1016/j.pbb.2010.06.003. Epub 2010 Jun 18.
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History
Started
Jan 2017
Main results due
Jan 2018
Finished
Jan 2018
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