Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Commission Errors
研究概览
简要总结
The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.
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)
盲法说明
placebo controlled, double-blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria: Healthy non-treatment seeking adults (age 18 to 60, N = 40) who report
- •(a) infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline, or
- •(b) report frequent cannabis use defined as > 5 days per week for > 1 year with a positive THC urine toxicology at baseline.
- •These criteria were selected to target individuals with low and high-frequency cannabis use in order to examine the direct effect of tolerance on study outcome measures.
排除标准
- •(1) meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine,
- •(2) are currently receiving or interested in immediately receiving behavioral treatment or medication for cannabis cessation,
- •(3) current use of any medications that could affect study outcomes,
- •(4) test positive for drugs of abuse (other than cannabis) and/or breath alcohol test at study admission,
- •(5) have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity,
- •(6) are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding,
- •(7) have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina), or (8) are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
研究组 & 干预措施
0 mg THC
Inhaled Cannabis - 0 mg THC
干预措施: Cannabis (Drug)
5 mg THC
Inhaled cannabis - 5 mg THC
干预措施: Cannabis (Drug)
30 mg THC
Inhaled cannabis - 30 mg THC
干预措施: Cannabis (Drug)
结局指标
主要结局
Commission Errors
时间窗: pre-administration, post-administration, 2, 4 hours
The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Commission errors is measured by calculating the number of trials participants incorrectly push the spacebar in the presence of "X" stimulus.
Omission Errors
时间窗: pre-administration, post-administration, 2, 4 hours
The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Omission errors is measured by calculating the number of trials participants fail to push the spacebar in the presence of a letter that is not an "X" stimulus.
Reaction Time
时间窗: pre-administration, post-administration, 2, 4 hours
The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time is measured by calculating the duration between the presentation of a letter other than "X", and the correct response of a spacebar push.
Visuomotor Index
时间窗: pre-administration, post-administration, 2, 4 hours
The visuomotor index score is calculated by mathematically integrating five measures of oculomotor fixation performance and two measures of accuracy into a single score during fixation and accuracy tasks, respectively. Test of visual fixation to measure microsaccades, spontaneous nystagmus, and gaze-evoked nystagmus.
Reaction Time Standard Error
时间窗: pre-administration, post-administration, 2, 4 hours
The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time standard error is measured by calculating the standard error of the mean of the reaction time.
次要结局
- Saccade Speed(Pre-administration, post-administration, 2, 4 hours)
- Visually Guided Oculomotor Performance(Pre-administration, post-administration, 2, 4 hours)
- Antisaccade(Pre-administration, post-administration, 2, 4 hours)
- Memory-Guided(Pre-administration, post-administration, 2, 4 hours)