The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- 25 foot walk test
研究概览
简要总结
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.
详细描述
Prospective participants will be recruited from the Integrative Neurophysiology Laboratory's (INPL) participant database, the clinical practice of Dr. William Shaffer, Banner Health, Greeley Colorado, through advertisements in the Colorado and Wyoming Chapter of the National MS Society newsletters, and via the Rocky Mountain MS Newsletter. All experimental procedures will be performed in the INPL (Director: Thorsten Rudroff, PhD, FACSM).
Interested individuals will perform an initial screening via an online questionnaire, hosted by Qualtrics, which has a contract with the College of Health and Human Sciences.
Contact information for the prospective participants will be accessible only to the research staff according to HIPAA regulations. After completion of the online screening form, INPL personnel will contact eligible participants via phone and establish 100 total participants. After participants have been identified, INPL staff will schedule the participants' first visit. Eligibility requirements for this study are: medically diagnosed with MS, 21-74 years of age, and moderate disability (Patient Determined Disease Steps score 2-6). The investigators will recruit people with MS who are planning to use medical marijuana for the first time for the treatment of their symptoms. 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. Marijuana and placebo cigarettes will be ordered from the NIDA (National Institute on Drug Abuse) Drug Supply Program and stored at a designated room in the Department of Health and Exercise Science (HES) at Colorado State University (CSU).
The experimental protocol for this study consists of one testing session that will be performed four times:
Once before the assignment of marijuana product and then once a month during this 3 month longitudinal study. All experiments will be conducted by research personnel (outcome assessors) who are blinded to product assignment. Prior to each session the clinical trial administrator (CTA) will perform an urine analysis assessment for Δ9-tetrahydrocannabinol (THC) to confirm compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind placebo controlled
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo group: THC (0%) / CBD (0%)
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.
干预措施: Placebo (Drug)
CBD group:THC (<1%) / CBD (>10%)
The dose for the CBD group (THC (<1%) / CBD (>10%)) is 1 gram medical marijuana cigarette smoked once per day for 3 months.
干预措施: Medical Marijuana (Drug)
THC group: THC (>10%) / CBD (<1%) THC group
The dose for the THC group (THC (>10%) / CBD (<1%)) is 1 gram medical marijuana cigarette smoked once per day for 3 months.
干预措施: Medical Marijuana (Drug)
Mixed group:THC (5-10%) / CBD (5-10%)
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.
干预措施: Medical Marijuana (Drug)
结局指标
主要结局
25 foot walk test
时间窗: 1 year
Time (min)
Becks Depression Inventory
时间窗: 1 year
Numeric Scale
9 hole peg test
时间窗: 1 year
Time (sec)
Quality of Life
时间窗: 1 year
Numeric Scale
Leg Strength
时间窗: 1 year
kg
Fatigue Severity Scale
时间窗: 1 year
Numeric Scale
Paced Auditory Serial Addition Test
时间窗: 1 year
Time (min)
Pain Effect Scale.
时间窗: 1 year
Numeric Scale
次要结局
- Fat Mass(1 year)
- Lean Body Mass(1 year)
研究者
Thorsten Rudroff
Assistant Professor
Colorado State University