MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Global Cognitive Ability (GCA)
研究概览
简要总结
The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women must be >1 year post-menopausal.
- •English as a first/primary language.
- •Functional visual and auditory acuity (aided or unaided) to complete tests.
- •Capacity to independently provide informed consent and function at an intellectual level sufficient to allow completion of all instruments.
- •Currently meets DSM-5 criteria for CUD or uses cannabis at least 4 days per week
- •Consent to abstain from alcohol and cannabis use for >12 hours prior to Study Visit (Day 0), and TSST (Day 8).
- •Consent to abstain from all drugs other than cannabis or nicotine for the duration of the study.
排除标准
- •Meet DSM-5 criteria for moderate or severe alcohol or substance use disorder (other than nicotine or cannabis) within the last 12 months.
- •History of major neurocognitive disorder or developmental disorder per DSM-
- •A Telephone Interview for Cognitive Status (TICS) score of less than or equal to
- •Significant or unstable medical condition/s that impact cognition as deemed by study investigators, such as active significant cardiac, cerebrovascular, neoplastic, infectious, or metabolic disease, or longstanding and intractable severe mental illness (e.g. schizophrenia spectrum disorder, bipolar disorder).
- •Daily use of medications that adversely impact cognition in aging (i.e. anticholinergics and sedatives).
- •Current suicidal or homicidal ideation/risk.
- •Unable to complete/comply with procedures or pose threat to research staff.
- •Standard MRI contraindications (e.g., implants, claustrophobia).
- •Women who are pregnant, nursing, or of childbearing potential and not practicing and effective means of birth control.
结局指标
主要结局
Global Cognitive Ability (GCA)
时间窗: Day 0
The primary outcome is the mean Global Cognitive Ability (GCA) z-score, which is a psychometrically robust, factor analytically-derived, demographically-normed index of global cognitive function. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.
次要结局
未报告次要终点
研究者
Andreana Benitez
Assistant Professor
Medical University of South Carolina