Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Alcohol Use Frequency
研究概览
简要总结
The goal of this clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:
Does 4 weeks of nightly cannabdiol use:
- improve sleep quality and time spent in REM sleep?
- decrease alcohol use and alcohol craving?
- pose any safety risks?
Researchers will compare cannabidiol to a placebo (a look-alike substance that contains no drug).
Participants will:
Take cannabidiol every night for 4 weeks Visit the clinic once at the beginning and once at the end of the study Wear an activity monitoring watch while in the study Complete an at-home sleep test both at the beginning and the end of the study Check in once a week with researchers via video conference
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Self reported poor sleep quality (PSQI score >5)
- •Hazardous or harmful levels of alcohol consumption (MINI AUD score ≧2)
- •No current moderate or severe alcohol withdrawal symptoms (CIWA-Ar)
- •For female participants of childbearing potential: Not pregnant or lactating at the time of study enrollment or trying to become pregnant as confirmed by urine preg. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
- •For female participants of childbearing potential: Agree to use a highly effective contraception method (i.e., a method with a failure rate of less than 1 percent per year when used consistently and correctly) starting at least five days before you begin the study and continuing for full participation.
- •No current use of sleep medications including CBD in the last 90 days
- •No history of complicated alcohol withdrawal (i.e., seizure, delirium tremens, or alcohol hallucinosis).
- •No current or past 6 months active suicidal ideation or suicidal behavior
- •No current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
- •No current cannabis use disorder (MINI SUD for cannabis score ≧2)
- •History of previous exposure to guaiol through CBD or other cannabis product
排除标准
- •Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- •Greater than low risk for obstructive sleep apnea (STOP-BANG <=4 or Moderate or greater risk as calculated by Nox Noxturnal Software from baseline PSG data)
- •Current use of medications known to have major interactions with Epidiolex (e.g., brexanolone, buprenorphine, colchicine, esketamine, fezolinetant, ketamine, leflunomide, levoketoconazole, levomethadyl acetate, lomitapide, mipomersen, morphine, pexidartinib, pralsetinib, propoxyphene, relugolix, sodium oxybate, teriflunomide, and venetoclax)
- •Current use of anti-psychotic medications
- •Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
- •History of hypersensitivity reactions to cannabidiol
- •Liver function test (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits at baseline
- •Moderate or severe liver disease
- •Allergy or aversion to gelatin (softgels contain porcine gelatin)
- •Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days or positive screening on urine toxicology test at Baseline visit.
- •Uncontrolled hypertension
- •Blood pressure findings concerning for moderate or severe alcohol withdrawal at baseline
- •Abnormal resting heart rate, defined as <60 bpm or >100 bpm at baseline
研究组 & 干预措施
300mg oral cannabidiol
干预措施: Cannabidiol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Alcohol Use Frequency
时间窗: 4 weeks
Measure of frequency of alcohol use using the Timeline Followback
Sleep Efficiency
时间窗: 4 weeks
A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch
Total Sleep Time
时间窗: 4 weeks
An average of total time spent asleep each night as measured by a continuously worn actigraphy watch
Time Spent in REM
时间窗: 4 weeks
Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography
Subjective Sleep Quality
时间窗: 4 weeks
Self reported sleep quality using the Patient Reported Outcomes Measurement Information Scale (PROMIS) Sleep Disturbance Subscale. The scale consists of eight items with a minimum score of eight and a maximum score of 40. Higher scores correspond to worse sleep quality.
Alcohol Craving
时间窗: 4 weeks
Subjective report of alcohol craving using the Penn Alcohol Craving Scale. Scores range from 0 to 35, with higher scores corresponding to greater alcohol craving.
次要结局
- Mood and Stress(4 weeks)
研究者
Renée Martin-Willett
Assistant Research Professor
University of Colorado, Boulder