Safety of Acute and Repeated Doses of Natural Medical Marijuana Products and Effects on Subjective and Physiological Responses to Stress and Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain Ratings
研究概览
简要总结
This proposal aims to systematically examine the safety and pharmacokinetic/pharmacodynamic profile and the physiologic, neuroendocrine and behavioral stress and pain responses to acute single doses and repeated dosing of oral tablet formulation of natural Cannabidiol (CBD) alone and in combination with Tetrahydrocannabinol and matched Placebo (PLA).
详细描述
This proposal aims to systematically examine the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile and the physiologic, neuroendocrine and behavioral stress and pain responses to acute single doses and repeated dosing of oral tablet formulation of natural Cannabidiol (CBD) at 40 mg and 100 mg alone and in combination with Tetrahydrocannabinol (THC) at 10, 20 and 30 mg, and matched Placebo (PLA) under the following specific aims:
Aim 1: To assess the safety and PK/PD profile of acute single doses of natural oral tablet of CBD (40 mg, 100 mg), and the CBD/THC combination (40/10, 40/20 and 100/30 mg) and matching placebo (PLA) over six separate sessions one week apart in healthy adult men and women who are current recreational cannabis users (STUDY 1).
Aim 2: To examine the effects of separate CBD, THC, CBD/THC combination vs. PLA on subjective, physiological, neuroendocrine, cognitive and behavioral measures of stress, pain and anxiety at baseline and under acute pain provocation using an adapted Cold Pressor Test (CPT) in STUDY 1.
Aim 3: To examine the safety and tolerability of the two specific doses of CBD/THC, selected on the basis of best PK/PD and tolerability profile from Study 1 vs. PLA on baseline and CPT provoked pain in individuals with chronic pain over a 7-day repeated dosing (STUDY 2).
Study 1:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, placebo controlled, parallel group design
入排标准
- 年龄范围
- 21 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and write English;
- •Recreational cannabis use with a minimum history recent use of at least one joint of smoked marijuana or marijuana edible or other equivalent form;
- •Current chronic pain, as defined by the International Classification of Diseases (ICD)-10, and stabilized for a minimum of 2 weeks on pain medication, (minimum pain ratings of 4 on a 10-point scale) and agree to not change pain medication during course of the study;
- •Body Mass Index (BMI) in the 18-36 range;
排除标准
- •Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
- •Any Current moderate/severe Substance Use Disorder, including alcohol and cannabis.
- •Women who are nursing or have premenstrual dysphoric disorder;
- •Women who are pregnant as determined by the urine pregnancy test at each assessment period;
- •Inability to give informed consent;
- •Traumatic brain injury or loss of consciousness;
- •Individuals with current or past history of seizure disorders;
研究组 & 干预措施
Active Dose 1
Participants will receive the most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.
干预措施: Active CBD/THC Dose 1 (Drug)
Matching Placebo
Participants will receive a placebo with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.
干预措施: matched placebo comparator (Drug)
Active Dose 2
Participants will receive the second most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions
干预措施: Active CBD/THC Dose 2 (Drug)
结局指标
主要结局
Pain Ratings
时间窗: Day 1 and 7 provocation during 7-day treatment period
Change in provoked pain ratings on day 1 and day 7 on visual analog scale of pain (range 0-10)
次要结局
- Anxiety Ratings(Day 1 and 7 provocation during 7-day treatment period)
研究者
RAJITA SINHA
Principal Investigator
Yale University