Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 385
- 试验地点
- 2
- 主要终点
- Subjective Motor Function
研究概览
简要总结
Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 60 years of age
- •Able to provide informed consent
- •Must have used a cannabis product at least once with no negative effects
- •Must not have been regularly using any cannabis products (<3x/month) in the last 6 months
- •Female participants must be postmenopausal
- •Liver function tests (Alanine transaminase (ALT) and
- •Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age
- •Must be currently taking medication/s for pain, sleep, and/or mood
排除标准
- •Blood alcohol level > 0 at screening (to sign consent form)
- •Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
- •Past or current diagnosis, or family history of diagnosis of psychosis
- •Current use of anti-epileptic medications (e.g. clobazam, sodium valproate)
- •Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide).
- •Current use of antipsychotic medications
- •Currently undergoing chemotherapy (to prevent drug interactions)
研究组 & 干预措施
Full-Spectrum Hemp-Derived CBD (fsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
干预措施: fsCBD Cannabidiol (Drug)
Placebo
干预措施: Placebo (Drug)
Broad-Spectrum Hemp-Derived CBD (bsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD)
干预措施: bsCBD Cannabidiol (Drug)
结局指标
主要结局
Subjective Motor Function
时间窗: Baseline, 4 weeks, 8 weeks
Activities-specific Balance Confidence Scale. Participants asked about confidence in completion of 16 daily tasks without losing balance or becoming unsteady. Responses are on a scale from no confidence to completely confident, with higher aggregate scores meaning higher subjective motor function.
Depression
时间窗: Baseline, 4 weeks, 8 weeks
Beck Depression Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher depression. Total scores are between 0-63, where anything above 40 suggest potentially concerning levels of depression.
Inhibitory Control
时间窗: Baseline, 4 weeks, 8 weeks
Flanker Inhibitory Control and Attention Task
Pain Intensity
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 1-5, with 1 being no pain and 5 being very severe. Assessed with 2 items as well as current pain.
Sleep-Related Impairment
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment
Balance
时间窗: Baseline, 4 weeks, 8 weeks
Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.
Anxiety
时间窗: Baseline, 4 weeks, 8 weeks
Beck Anxiety Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher anxiety. Total scores are between 0-63, where anything above 36 suggest potentially concerning levels of anxiety.
Blood Cytokine Levels
时间窗: Baseline, 4 weeks, 8 weeks
Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-α, IL-β, and CRP)
Cognitive Function
时间窗: Baseline, 4 weeks, 8 weeks
Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.
Sleep Disturbance
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.
Depression/Anxiety
时间窗: Baseline, 4 weeks, 8 weeks
Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.
Change in Condition
时间窗: 4 weeks, 8 weeks
Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.
Memory
时间窗: Baseline, 4 weeks, 8 weeks
Rey auditory verbal learning test assesses verbal memory.
Drug Effects
时间窗: 4 weeks, 8 weeks
Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.
Pain Intensity and Interference
时间窗: Baseline, 4 Weeks, 8 Weeks
Brief Pain Inventory - Short Form (BPI - SF). Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain.
Cognitive Ability
时间窗: Baseline, 4 weeks, 8 weeks
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
次要结局
- Polypharmacy-Pain Medications(Baseline, 4 weeks, 8 weeks)
- Sleep Quality(Baseline, 4 weeks, 8 weeks)
- Polypharmacy-Sleep Medications(Baseline, 4 weeks, 8 weeks)
- Polypharmacy-Psychiatric Medications(Baseline, 4 weeks, 8 weeks)
- Strength and Endurance(Baseline, 4 weeks, 8 weeks)
研究者
Angela Bryan
Professor
University of Colorado, Boulder