The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Nucleus accumbens glutamate
研究概览
简要总结
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent
- •Meet DSM-5 criteria for CUD
- •Report cannabis use ≥4 days/week on average in the last 30 days at screening
- •Provide a THC-positive urine sample at screening
- •BMI between 18-30 kg/m2
- •Regular menstrual cycle (females only)
- •Willing to use non-hormonal birth control for the duration of study participation (females only)
排除标准
- •Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
- •Urinalysis results indicative of recent drug use other than cannabis
- •Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
- •Current treatment-seeking for CUD or other SUDs
- •Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
- •Females who are pregnant, nursing, or planning to become pregnant
- •MRI contraindications (e.g., metallic implants, claustrophobia)
- •Significant history of nausea associated with the use of cannabis and/or THC
- •History of cardiac or seizure disorders
- •Allergy to sesame oil
研究组 & 干预措施
Males
干预措施: Placebo (Drug)
Females
干预措施: Placebo (Drug)
Males
干预措施: Dronabinol (Drug)
Females
干预措施: Dronabinol (Drug)
结局指标
主要结局
Nucleus accumbens glutamate
时间窗: 2 hours post-dose
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Drug Effects Questionnaire (DEQ) - Like Drug Effect
时间窗: 0-7 hours post-dose
Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Sex differences in genetics
时间窗: Day 1
Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system
次要结局
- Dorsal striatal glutamate(2 hours post-dose)
- Drug Effects Questionnaire (DEQ) - Want More(0-7 hours post-dose)
- Drug Effects Questionnaire (DEQ) - High(0-7 hours post-dose)
研究者
Erin Martin
Assistant Professor
Medical University of South Carolina