Research Investigating Drug Effects-2 (RiDE-2)
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Recent Substance Use
研究概览
简要总结
The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-21 at eligibility visit
- •body mass index of 18.5-30
- •report using cannabis ≥10 times in their life and ≥1 time in the past 3 months, but <7 days a week (daily)
- •medically and neurologically healthy
- •score of ≥0.25 on the Personality Inventory for DSM-5 (PID-5) Anhedonia subscale
排除标准
- •positive urine drug screen (UDS; except for THC) and/or positive saliva THC test
- •contraindication for fMRI BOLD study (e.g., metal implants)
- •severe mental illness (e.g., psychosis, mania, lifetime moderate-to-severe SUD (including moderate-to-severe CUD))
- •heavy nicotine use in the past month (>20 cigarettes per week or electronic nicotine delivery system (ENDS) use equivalent
- •night shift work
- •females who are currently pregnant confirmed by urine pregnancy test, are planning pregnancy, or are lactating
- •unwilling/unable to sign informed consent document
- •current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol/Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
- •physical or neurological diagnoses (e.g., cancer, diabetes, seizure disorder, Parkinson's, Multiple Sclerosis, loss of consciousness >10 min., etc.) that in the opinion of the Study Physician and Investigators could increase safety risks or influence the findings
- •currently taking any medication that could interact with a single dose of Δ9-THC
研究组 & 干预措施
Placebo oral capsule
Participants will receive a placebo at their first or second laboratory visit.
干预措施: Placebo Oral Capsule (Drug)
THC
Participants will receive THC (7.5 mg) at their first or second laboratory visit.
干预措施: THC (Drug)
结局指标
主要结局
Recent Substance Use
时间窗: Baseline screening, baseline drug administration, and every 6 months over two years of follow-up
Participants will complete the 6-month Timeline Follow-Back (TLFB) and Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU) to assess recent substance use. This measure will capture the frequency of substance use during the past 6 months, with greater values indicating more frequent substance use.
CUD/SUD Symptoms
时间窗: Baseline screening and yearly over the two-year follow-up.
Participants will complete the SCID CUD diagnosis and symptom assessment at baseline screening and yearly follow-ups to evaluate the presence and severity of cannabis use disorder (CUD) and other substance use disorder (SUD) symptoms.
Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)
时间窗: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Participants will complete the Bandit task during fMRI scanning. A behavioral measure of learning rate (alpha parameter) will be derived from computational models based on the Rescorla-Wagner (RW) model, with higher learning rates indicating greater learning and adaptation to reward contingencies.
Neural Reward Anticipation - fMRI response to reward anticipation (MID)
时间窗: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Participants will complete the Monetary Incentive Delay (MID) task during fMRI scanning to assess neural activation related to reward anticipation. Greater activation in reward-related brain regions (e.g., striatum, prefrontal cortex) indicates greater neural sensitivity to anticipated rewards and the impact of THC on reward processing.
Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter)
时间窗: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Participants will complete the Bandit task during fMRI scanning, and a behavioral measure of reward sensitivity will be derived from the Rescorla-Wagner (RW) model. Greater values indicate higher sensitivity to rewards and a stronger preference for rewarding outcomes.
Neural Encoding of Reward Prediction Errors - fMRI response to reward prediction errors (Bandit Task)
时间窗: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Participants will complete the Bandit task during fMRI scanning. fMRI analysis will focus on trial-wise neural encoding of prediction errors, with greater activation indicating more salient reward learning signals in response to prediction errors, reflecting how the brain processes unexpected outcomes during reward learning.
次要结局
未报告次要终点