Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Change in FACT-Cog
研究概览
简要总结
Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.
详细描述
Older adults are currently the fastest growing group of cannabis users in the U.S, and are more likely to use cannabis for medicinal purposes (e.g., pain, trouble sleeping, depression/anxiety) than for recreational purposes, despite having little data to guide their decisions about what type of product to use. This project utilizes a patient-centered observational design to recruit and assess older adults who are interested in using cannabis compared to a control group who is not interested in cannabis use. Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 60 years of age
- •Able to provide informed consent
- •Cannabis Users: Must not currently use cannabis more than 7 times per month and not for pain, sleep, depression or anxiety in the past 6 months
- •Cannabis Non-users: Should NOT have used cannabis in the past year and have not used regularly (e.g., more than weekly) for more than one year in the past 20 years
- •Cannabis Users: Must be interested in using cannabis for at least one of the following complains: pain, sleep problems, depression, anxiety
- •Non-users: Must NOT be interested in using cannabis but have at least one of the following complaints: pain, sleep problems, depression, anxiety
- •Cannabis users: must be comfortable using edible cannabis and having a mobile laboratory (Dodge van) parked at their home
- •Female participants must be postmenopausal
- •Comfortable reading and writing in English
- •Planning to stay in the Boulder/Denver area for the next month
- •Must be comfortable with blood draws
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 of psychosis
- •Current use of antipsychotic medications
- •Heavy drinking; Alcohol Use Disorder Identification Test (AUDIT) test score >8
- •Inability/discomfort/unwillingness with getting in and out of the mobile laboratory van
- •History of vertigo or falls within the past six months
结局指标
主要结局
Change in FACT-Cog
时间窗: Baseline, 1-month, 2 months, 3 months, 4 months
Self-report of whether cognitive function has improved, gotten worse, or stayed the same
Change in Rey Auditory Verbal Learning Task
时间窗: Baseline, 1-month
Test of whether working memory has improved, gotten worse, or stayed the same
Balance Task
时间窗: 1-month
Stability with eyes closed and eyes open
Change in Activities Specific Balance Confidence Scale
时间窗: Baseline, 1-month, 2 months, 3 months, 4 months
Self-report of whether confidence in balance has improved, gotten worse, or stayed the same
Change in Patient Global Impression of Change
时间窗: 1-month, 2 months, 3 months, 4 months
Self report of whether symptoms have improved, gotten worse, or stayed the same
次要结局
- Change in Depression Anxiety Stress Scale(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in pain Intensity past 7 days(Baseline, 1-month, 2 months, 3 months, 4 months)
- Current Pain Intensity(1-month)
- Addiction Research Center Inventory Marijuana Survey(1-month)
- Profile of Mood States(1-month)
- Change in Online Timeline Follow-back Assessment(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in Marijuana Consumption Questionnaire(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in Polypharmacy(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in PROMIS Sleep Disturbance(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in PROMIS Fatigue(Baseline, 1-month, 2 months, 3 months, 4 months)
- Change in PROMIS Pain Interference(Baseline, 1-month, 2 months, 3 months, 4 months)
- Drug Effects Questionnaire(1-month)
- Change in PROMIS Global Health(Baseline, 1-month, 2 months, 3 months, 4 months)
研究者
Angela Bryan
Professor
University of Colorado, Boulder