Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
研究概览
简要总结
The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.
详细描述
This is an inpatient, single-blind, non-randomized, 1-sequence study involving healthy subjects who have used opioids for recreational use. The primary objective of the study is to establish the pharmacokinetic parameters of morphine 30 mg when administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
- •Males and females 18 to 55 years of age, inclusive.
- •Body mass index (BMI) ranging from 18 to 34 kg/m2, inclusive, and body weight of 56 kg and above.
- •Adequate venous access as assessed by an investigator at screening.
- •No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
- •Recreational opioid use (i.e., defined as prescription opioid use for nontherapeutic purposes on at least 3 occasions within the previous year and at least once in the 12 weeks prior to screening), experienced in using opioids of approximately 30 mg morphine equivalents and not seeking treatment for Opioid Use Disorder.
- •If of childbearing potential, a female study subject must agree to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study and for at least 30 days after the last dose of the study medication
- •An acceptable method of contraception includes abstinence from heterosexual intercourse or intrauterine device (with or without hormones)
- •OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication. Oral contraceptives are prohibited.
- •If a female of non-childbearing potential, she should be surgically sterile (i.e., has undergone compete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by FSH level.
- •A male study subject must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
- •Agree not to ingest alcohol, drinks containing caffeine >500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
- •Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- •Must be willing and able to abide by all study requirements and restrictions.
排除标准
- •Contact site directly for more information
研究组 & 干预措施
CBD (350 mg)
CBD 350 mg twice per day for 3 days
干预措施: Morphine Sulfate (Drug)
CBD (700 mg)
CBD 700 mg twice per day for 3 days
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
时间窗: 3 day
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
时间窗: 3 day
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD
时间窗: 3 day
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
次要结局
- Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD(3 day)
- Establish the Apparent Clearance of CBD when administered orally with morphine(3 day)
- Establish the Maximum Plasma Concentration (Cmax) of CBD when administered orally with morphine(3 day)
- Establish the Time of Maximum Plasma Concentration (Tmax) of CBD when administered orally with morphine(3 day)
- Establish the Area Under the Curve of the dosing period of CBD when administered orally with morphine(3 day)
- Establish the terminal half-life of CBD when administered orally with morphine(3 day)
- Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD(3 day)
- Establish the Apparent Clearance of morphine when administered orally with and without CBD(3 day)
- Establish the terminal-phase elimination rate constant of CBD when administered orally with morphine(3 day)
- Safety and Tolerability of morphine when administered orally with or without CBD by collecting vital signs and recording treatment emergent adverse events(7 + 3/5 days)