Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Analgesia
研究概览
简要总结
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.
详细描述
The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of 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 and non-lactating females aged 21-55 years
- •• Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening
- •Not currently seeking treatment for their cannabis use
- •Have a Body Mass Index from 18.5 - 34kg/m
- •Able to perform all study procedures
- •Must be using a contraceptive (hormonal or barrier methods)
- •Females must not be lactating
排除标准
- •Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD
- •Any other Axis I disorder
- •• Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer)
- •If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are 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 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
- •Currently enrolled in another research protocol
- •Not using a contraceptive method (hormonal or barrier methods)
- •Insensitivity to the cold water stimulus of the Cold Pressor Test
- •Any disorders that might make cannabis administration hazardous are exclusionary, as determined by the evaluating physician
研究组 & 干预措施
Placebo
0 mg CBG, 0 mg THC
干预措施: Placebo (Drug)
Low strength CBG
5 mg CBG, 0 mg THC
干预措施: Low CBG (Drug)
High strength CBG
15 mg CBG, 0 mg THC
干预措施: High CBG (Drug)
Low strength THC
0 mg CBG, 5 mg THC
干预措施: Low THC (Drug)
High strength THC
0 mg CBG, 30 mg THC
干预措施: High THC (Drug)
Low strength CBG + Low strength THC
5 mg CBG + 5 mg THC
干预措施: Low CBG (Drug)
Low strength CBG + Low strength THC
5 mg CBG + 5 mg THC
干预措施: Low THC (Drug)
Low strength CBG + High strength THC
5 mg CBG + 15 mg THC
干预措施: Low CBG (Drug)
Low strength CBG + High strength THC
5 mg CBG + 15 mg THC
干预措施: High THC (Drug)
High strength CBG + Low strength THC
15 mg CBG + 5 mg THC
干预措施: High CBG (Drug)
High strength CBG + Low strength THC
15 mg CBG + 5 mg THC
干预措施: Low THC (Drug)
High strength CBG + High strength THC
15 mg CBG + 15 mg THC
干预措施: High CBG (Drug)
High strength CBG + High strength THC
15 mg CBG + 15 mg THC
干预措施: High THC (Drug)
结局指标
主要结局
Analgesia
时间窗: 7 hours
Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold.
Appetite stimulation
时间窗: 7 hours
Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation.
Abuse liability
时间窗: 7 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability.
次要结局
- Subjective ratings of intoxication(7 hours)
- Subjective ratings of pain(7 hours)
研究者
Ziva D. Cooper, PhD
Associate Professor
University of California, Los Angeles