The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis

NCT03172741 | Withdrawn Phase 2

• 1 other identifier: 16-6964H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Cannabis

Outcome Measures

Primary Outcomes (8)

• Leg Strength

  kg

  1 year

• Fatigue Severity Scale

  Numeric Scale

  1 year

• 25 foot walk test

  Time (min)

  1 year

• 9 hole peg test

  Time (sec)

  1 year

• Paced Auditory Serial Addition Test

  Time (min)

  1 year

• Becks Depression Inventory

  Numeric Scale

  1 year

• Quality of Life

  Numeric Scale

  1 year

• Pain Effect Scale.

  Numeric Scale

  1 year

Secondary Outcomes (2)

• Fat Mass

  1 year

• Lean Body Mass

  1 year

Study Arms (4)

Placebo group: THC (0%) / CBD (0%)

PLACEBO COMPARATOR

The matching dose for high THC, high CBD or mixed CBD/THC is a 1 gram placebo cigarette (THC (0%) / CBD (0%)) smoked once per day of for 3 months.

Drug: Placebo

CBD group:THC (<1%) / CBD (>10%)

EXPERIMENTAL

The dose for the CBD group (THC (\<1%) / CBD (\>10%)) is 1 gram medical marijuana cigarette smoked once per day for 3 months.

Drug: Medical Marijuana

THC group: THC (>10%) / CBD (<1%) THC group

EXPERIMENTAL

The dose for the THC group (THC (\>10%) / CBD (\<1%)) is 1 gram medical marijuana cigarette smoked once per day for 3 months.

Drug: Medical Marijuana

Mixed group:THC (5-10%) / CBD (5-10%)

EXPERIMENTAL

The dose for the mixed group THC (5-10%) / CBD (5-10%) ) is 1 gram medical marijuana cigarette smoked once per day for 3 months.

Drug: Medical Marijuana

Interventions

Medical Marijuana DRUG

1-gram marijuana cigarette smoked once per day for 3 months

Also known as: Cannabis, Tetrahydrocannabinol, Cannabidiol

CBD group:THC (<1%) / CBD (>10%); Mixed group:THC (5-10%) / CBD (5-10%); THC group: THC (>10%) / CBD (<1%) THC group

Placebo DRUG

Matching 1 gram placebo cigarette smoked once per day for 3 months

Placebo group: THC (0%) / CBD (0%)

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead

Related Publications (3)

• 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.

  PMID: 26951347 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.

  PMID: 24861632 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.

  PMID: 20600251 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Marijuana Abuse

Interventions

Medical Marijuana; nabiximols; Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Thorsten Rudroff, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind placebo controlled
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 1, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share