Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Analgesia as measured using the Cold Pressor Test
研究概览
简要总结
The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.
详细描述
The overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female aged 21-55 years
- •Report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening
- •Not currently seeking treatment for cannabis use
- •Urine test positive for recent cannabis use
- •Have a Body Mass Index from 18.5 - 34kg/m
- •Able to perform all study procedures
- •Must be using a contraceptive method (hormonal or barrier methods)
排除标准
- •Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or mild CUD
- •Report using other illicit drugs in the prior 4 weeks
- •• If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
- •Current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes
- •Current pain
- •Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
- •History of an allergic reaction or adverse reaction to cannabis is exclusionary.
- •History of respiratory illness or current respiratory illness
- •History of seizure disorder or current seizure disorder
- •Insensitivity to the cold water stimulus of the Cold Pressor Test
- •Currently enrolled in another research protocol
- •Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)
- •Not using a contraceptive method (hormonal or barrier methods)
- •The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
研究组 & 干预措施
High THC + High BCP
15 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: High Beta-Caryophyllene (Drug)
Low strength BCP
0 mg THC, 0 mg myrcene, 0.5 mg BCP
干预措施: Low Beta-Caryophyllene (Drug)
Low THC + Low myrcene
5 mg THC, 0.5 mg myrcene, 0 mg BCP
干预措施: Low THC (Drug)
Low THC + High myrcene
5 mg THC, 12.0 mg myrcene, 0 mg BCP
干预措施: Low THC (Drug)
Low THC + Low BCP
5 mg THC, 0 mg myrcene, 0.5 mg BCP
干预措施: Low Beta-Caryophyllene (Drug)
High strength BCP
15 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: High Beta-Caryophyllene (Drug)
Low THC + High myrcene
5 mg THC, 12.0 mg myrcene, 0 mg BCP
干预措施: High Myrcene (Drug)
High THC + Low myrcerne
15 mg THC, 0.5 mg myrcene, 0 mg BCP
干预措施: High THC (Drug)
Low THC + High BCP
5 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: Low THC (Drug)
High THC + Low BCP
15 mg THC, 0 mg myrcene, 0.5 mg BCP
干预措施: High THC (Drug)
High THC + Low BCP
15 mg THC, 0 mg myrcene, 0.5 mg BCP
干预措施: Low Beta-Caryophyllene (Drug)
High THC + High BCP
15 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: High THC (Drug)
Low strength THC
5 mg THC, 0 mg myrcene, 0 mg BCP
干预措施: Low THC (Drug)
Placebo
0 mg THC, 0 mg myrcene, 0 mg BCP
干预措施: Placebo (Drug)
Low THC + Low myrcene
5 mg THC, 0.5 mg myrcene, 0 mg BCP
干预措施: Low Myrcene (Drug)
Low strength myrcene
0 mg THC, 0.5 mg myrcene, 0 mg BCP
干预措施: Low Myrcene (Drug)
High strength myrcene
0 mg THC, 12.0 mg myrcene, 0 mg BCP
干预措施: High Myrcene (Drug)
High THC + Low myrcerne
15 mg THC, 0.5 mg myrcene, 0 mg BCP
干预措施: Low Myrcene (Drug)
High THC + High myrcene
15 mg THC, 12.0 mg myrcene, 0 mg BCP
干预措施: High Myrcene (Drug)
Higher strength THC
15 mg THC, 0 mg myrcene, 0 mg BCP
干预措施: High THC (Drug)
High strength BCP
15 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: High THC (Drug)
High THC + High myrcene
15 mg THC, 12.0 mg myrcene, 0 mg BCP
干预措施: High THC (Drug)
Low THC + Low BCP
5 mg THC, 0 mg myrcene, 0.5 mg BCP
干预措施: Low THC (Drug)
Low THC + High BCP
5 mg THC, 0 mg myrcene, 7.5 mg BCP
干预措施: High Beta-Caryophyllene (Drug)
结局指标
主要结局
Analgesia as measured using the Cold Pressor Test
时间窗: 7 hours
Pain threshold and pain tolerance assessed using the Cold Pressor Test
Subject-rated drug effects of abuse liability
时间窗: 7 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
次要结局
- Subject-rated drug effects of intoxication(7 hours)
- Subjective ratings of pain(7 hours)
研究者
Ziva D. Cooper, PhD
Associate Professor
University of California, Los Angeles