The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking, literate adults,
- •Male or female,
- •Between the ages of 18-55,
- •Body Mass Index from 18.5-32.0 kg/m2,
- •Not currently seeking treatment for cannabis or drug use,
- •Able to provide written informed consent and perform all study procedures,
- •If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
- •Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and
- •Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.
排除标准
- •Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
- •Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD]),
- •Current or past history of major psychiatric disorder that would limit ability to participate in the study,
- •Use of cannabis exclusively for medical reasons (no recreational use reported),
- •Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),
- •Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers,
- •Clinically significant abnormal ECG (as determined by study physician/cardiologist),
- •Clinically significant abnormal laboratory findings,
- •History of seizure disorder,
- •Clinically significant history of head injuries requiring medical management or long lasting sequalae, and
- •Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).
研究组 & 干预措施
CBD (Higher Dose)/Active Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Active Marijuana will be administered through a vaporizer.
干预措施: Active Inhaled Cannabis (Drug)
CBD (Medium Dose)/Placebo Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Cannabidiol, Medium Dose (Drug)
Placebo CBD/Active Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day.
Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.
干预措施: Placebo Cannabidiol (Drug)
CBD (Medium Dose)/Active Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Vaporized Marijuana: Active Marijuana administered through a vaporizer
Cannabidiol: Active cannabidiol will be administered orally
干预措施: Cannabidiol, Medium Dose (Drug)
CBD (Medium Dose)/Active Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Vaporized Marijuana: Active Marijuana administered through a vaporizer
Cannabidiol: Active cannabidiol will be administered orally
干预措施: Active Inhaled Cannabis (Drug)
CBD (Medium Dose)/Placebo Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Placebo Inhaled Cannabis (Drug)
CBD (Higher Dose)/Active Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Active Marijuana will be administered through a vaporizer.
干预措施: Cannabidiol, Higher Dose (Drug)
Placebo CBD/Placebo Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day.
Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally.
Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Placebo Inhaled Cannabis (Drug)
CBD (Higher Dose)/Placebo Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Cannabidiol, Higher Dose (Drug)
Placebo CBD/Active Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day.
Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.
干预措施: Active Inhaled Cannabis (Drug)
CBD (Higher Dose)/Placebo Inhaled Cannabis
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Placebo Inhaled Cannabis (Drug)
Placebo CBD/Placebo Inhaled Cannabis
Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day.
Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally.
Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
干预措施: Placebo Cannabidiol (Drug)
研究者
Hannah Harris
Assistant Professor
University of Kentucky